We are not a manufacturer and there are no local regulation or obligation that sales site shall apply ISO14971 to my knowledge. But, I heard from someone that we should do. Is there anyone that in similar situation?
If sales site should adopt ISO14971, anyone can advise how to? ISO14971 is very much focused on product related risk for its lifecycle and I don't have idea how to apply the standard for commercial process independently.
Any advice or idea sharing will be appreciated!
5 Tips for Medical Device Engineers on FDA Design Controls
If you are an engineer in the medical device industry, you probably have a love/hate relationship with the FDA-mandated design controls process. While implementing design controls can feel like a majo
- The practical guide is huge…but it still doesn’t contain all the details industry needs.
- The practical guide does not differentiate between new ISO 13485:2016 and old (2003/2012) requirements
- The Practical Guide’s guidance on the risk-based approach (perhaps one of the most significant changes to the 2016 standard) is limited.
I discuss these points in detail in my latest blog. What were you expecting of the guide? What did you like or dislike? What was helpful to you?
The Practical Guide to the ISO 13485:2016 Practical Guide
Three things to consider before picking up the ISO 13485:2016 Practical Guide Manufacturers everywhere have been waiting a year and a half for additional guidance on the requirements of ISO 13485:2…
Philips Healthcare Trick or Treat
If you have not been scared enough by Halloween, read this consent decree announcement made by the FDA on November 1 to Philips Healthcare concerning quality control issues with their automatic ext…
Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices
How to implement and maintain a risk-based CAPA process while avoiding the most common pitfalls at your medical device company.
1- " shall document a procedure"
2- "shall document procedures"?
Does 1 mean that we need to implement one procedure per subject ( internal audit, control of documents..) and 2 means that we can implement the requirements (example 7.3.9 design changes ) in other procedures ?
Do you know if the FDA can inspect your emails if you used email as a record as a proof of compliance?
Joe Hage: That’s because they're doing it so quickly we can afford the extra room, right?
Terry Sweeney: Well, right now they’re fully staffed.
Joe Hage: That was a joke.
Terry Sweeney: Ha, yes. It's a question of user fees going up, if this budget proposal goes through as it is, the user fees will go up by 71 percent starting in 2018. If there's a shortfall, that’ll go up even higher.
Joe Hage: So, can I think of it as pay for service?
Terry Sweeney: Oh yes, it's a user fee, definitely.
Joe Hage: If I don't need their counsel for clearance I don't need to pay?
Terry Sweeney: You know, you don't pay unless you need a clearance, but the question is most products coming to the market do require the FDA review. Very few do not, that are exempt from that review process. PMA pre-market approval, typically our new innovation technologies, could go up to almost $500,000 per submission. To pay for the review of the submission, no guarantee you'll get it cleared. But likewise, the De Novo and further 510(k) submission cost will go up right along with that.
Joe Hage: Any idea what those are?
Terry Sweeney: De Novo could go up close to $90,000, 510(k) could be up on the order of $20,000.
Joe Hage: Sounds like a start-up will need to do a seed round.
Terry Sweeney: Start-ups should be able to get some reduction in that was based on the size of their company. FDA will cut them a break on that, but larger companies, mid-sized, companies will be looking at those fees.
Joe Hage: Do you believe that this will impact small companies, and actually hinder innovation?
Terry Sweeney: Well again the availability of the reviewers and the ability for a small company to interact with those reviewers, will be impacted negatively if that budget goes through.
Joe Hage: As a counselor to Phillips but perhaps if you were engaging for small clients, how would you help them navigate this new reality?
Terry Sweeney: Not an easy question, they definitely have to get a regulatory adviser to help them out, whether it be on staff or somebody to consult with them that is knowledgeable these new areas. It's going be a brave new world out there for them, to go through this regulatory scheme. All bets are off! Things are looking good right now in 2017, but 2018 will be totally different.
Joe Hage: Will it be less expensive to get clearances overseas?
Terry Sweeney: Yeah, but it won't help you get to the United States, which is the big market so it's the most problematic situation.
Joe Hage: Does it further the argument that it's better to innovate in Europe first?
Terry Sweeney: You still have to pay for your product clearances in Europe. The industry pays a hundred percent of those, it's just that we're not used to having to pay these high fees to the US FDA.
If you want to learn more abou the FY 2018 user fees and the strategic implications, the following blog article was posted yesterday:
Applying for small business qualification is best approach to reduce you costs of FDA regulatory submissions. If you have not completed a small business qualification form before, you can learn how to prepare your application for small business qualification by registering for a webinar this Friday, September 8, 2017:
FDA User Fee Increase for FY 2018 – Strategic Implications
This article identifies strategic implications of the FDA user fee increase for FY 2018 that was published by the FDA last week.
Trends in EU regulation of software as medical device
Presentation at the Personal Connected Health Alliance about regulatory trends in EU regulation of software as medical device
New legal obligations and liability under MDR and IVDR
Presentation at the MedTech Summit in Amsterdam on 19 June 2017 on the product liability regime under the MDR and IVDR, its nexus with the EU Product Liability Directive and its impact on other provisions in the MDR / IVDR
The following webpage provides FDA guidance on software documentation required in 510(k) submissions: https://www.fda.gov/RegulatoryInformation/Guidances/ucm089543.htm.
To determine the level of concern, you need to answer 7 questions found in the guidance document. If all 7 questions are negative, then the software is a minor level of concern by default.
It is important to read all questions and answer the questions as if you were the FDA. In many companies, the people performing risk analysis will identify risks of delay in treatment as being insignificant risks. However, the FDA typically scores the potential severity of harm much higher. Therefore, it is important to review any guidance documentation provided for your product classification to see if the FDA has already identified the level of concern for your software. If a guidance exists, but the FDA does not specify the level of concern, I recommend sending an email to the person that is responsible for the guidance at the FDA.
For minor and moderate levels of concern, the guidance indicates that less documentation for software validation needs to be submitted as part of your 510(k) submission.
The guidance DOES NOT say that you need to do less software validation or document less. The FDA allows you to submit less documentation for a 510(k), but you still have to do the same work.
A new, 2-day 510(k) workshop will be hosted in Amsterdam by Factory-CRO and my consulting firm. The dates of the workshop are October 11-12, 2017. For more information, please visit the following webpage: http://medicaldeviceacademy.com/amsterdam-510k-workshop/ .
I can’t disclose fully yet, but this is a registered Class I med device, designed for disposable one-use treatment in the outer ear. Let’s assume IP, packaging, production (overseas), inventory are all complete and take a price of ~$10. It can be covered by reimbursement and is going to first be targeted to MDs (ENT, FP, GP, audiologists) and then later direct to ‘patients’ for home use via retail (mass market, pharmacy). So, pre-launch work is done, so how would we develop the channels and marketing of this product?
Thanks for your advice and comments. Shall we begin?!
The good new is that you have time to write your procedures and train your complaint handling unit properly. Most manufacturers are not upgrading their quality system to ISO 13485:2016 until 2018 or 2019. In addition, the some of the new EU regulations are not truly finalized, because the Eudamed database is not even ready for manufacturers to use yet.
What should be in your procedure?
Your procedure should be detailed enough to enable a person that has not submitted a mandatory problem report before to do so. In addition, you may need detailed instructions for importers or distributors of your device--who may be required to submit adverse event reports.
Well-written procedures typically state that you should review and update your risk management documentation when you are investigating complaints--especially when there is a new adverse event to report. That’s not good enough.
You really need your reporting procedure to reference your risk management process and to provide guidance for what information needs to be reviewed and updated. Ideally your risk management documentation should be aligned with reporting requirements so it is obvious which events require reporting and which events should not require reporting.
If you are interested in learning more about writing a reporting procedure, please review the blog I posted today: http://medicaldeviceacademy.com/blog/. The end of the blog also mentions a new training webinar on Canadian Device Licensing that will be live on Wednesday, May 24.
Our DHF is system based e.g. Cervical plate system including plate, screw and etc. I am wondering whether the design changes require same documentation including design input, output, verification, validation, review and transfer like formal design controls when the change occurrs including screw design changes, some of size addition to previous models without no changes to intended use. In my opinion, the above case indicates that design input is changed so it requires same documentation from input.
I read an article said that.. it is worthy to document DHF when the design plan, design input, design output changes and the risk analysis affected. I'm not clearly understood when I consider those "changes" occurred. Could anybody give me an easy example?
Thanks for reading my posting.
After your IFU is validated, and you obtain regulatory approval for your product, you may still need to make updates to your IFUs as new risks are identified. In order to decide whether you need to update your IFUs you need to gather post-market surveillance data.
Post-market surveillance is not just asking customers if they are satisfied. You need to continue to monitoring adverse event databases, your own complaint database and any service records to determine if there are any new risks and to verify that the risks you identified were accurately estimated with regard to severity and probability of occurrence of harm. In fact, clinical studies and PMS are the only way you can gather data regarding probability of occurrence of harm. When you design your post-market surveillance questions, make sure you include questions specifically targeting the residual risks you identify in your IFU. You should also ask, “What indications do you use this device for. Specifically, please identify the intended diagnosis, treatment and patient populations.” This wording is more effective than asking if a physician is using your product “off label.”
If you want to learn more about using a risk-based approach to developing IFUs, validating IFUs and performing post-market surveillance to monitor the effectiveness of your IFU, then visit my blog posting from earlier today (http://www.medicaldeviceacademy.com/blog) or the following webinar page to register for our webinar on Friday, April 21:
It would be really good to hear from anyone who has taken the plunge and transitioned to only ISO 13485, how did it go? How was the change received both internally and externally by customers and suppliers?
There are four causes for receiving an NSE letter. The first cause is: you failed to verify that the predicate is a legally marketed device. If your predicate was not registered and listed with the FDA (check using this link), then you should have submitted a pre-sub request to determine if the agency has any problem with using the device you chose as a predicate. This is an important question if the manufacturer is no longer in business and the product is no longer for sale.
The second cause is: you failed to evaluate the substantial equivalence of your device’s intended use with the predicate. The FDA typically will work with the company to modify the wording of FDA Form 3881 to ensure the intended use is equivalent or to make sure you provide clinical evidence to address the differences. In my pre-submission requests, I include a comparison document for the intended use to ensure that the FDA is aware of any differences in the intended use.
The third cause is: you failed to convince the FDA that technological differences do not raise different questions of safety and effectiveness. For each difference you must provide a justification for why the difference does not raise different issues or you must provide data to prove it. It is also possible that you were not aware of questions of safety and performance raised by technological differences. To avoid this problem you can submit a detailed device description and draft labeling to the FDA in a pre-sub meeting request.
The fourth cause is: you failed to provide data demonstrating equivalence.
For each difference you should determine an objective method for demonstrating that the difference is equivalent in safety and performance to the predicate. Your test method can be proposed to the FDA in a pre-sub request prior to testing. The FDA sees more than 3,000 companies propose testing methods to demonstrate equivalence each year. They have more experience than you do. Ask them in a pre-sub before you test anything.
In all four root causes identified above, you could benefit greatly from pre-sub meeting. The correction to your NSE letter may not be clear. You should consider requesting a pre-sub meeting as quickly as you can. Most companies choose not to submit a pre-sub meeting request, because they don’t want to wait 75-90 days. However, sometimes pre-sub meetings are scheduled sooner. In addition, 75-90 days is not as costly as receiving a second NSE letter.
If you want to learn more, read the complete article:
If you need help with your 510(k) submission, consider attending the 510(k) training workshop in Chicago on April 18: http://medicaldeviceacademy.com/chicago-510k-workshop/.
Earlier this year I recorded a webinar on the 4th edition of MEDDEV 2.7/1 for clinical evaluations, but the new European Medical Device Regulations requires additional changes to the clinical evaluation process. If you already have CE Marking, you have 3 years to gather the clinical data you need to meet the new requirements. If you don’t you will no longer be able to CE Mark your products--even for Class 1 devices.
If your device is not on the market yet, you need to understand how the new regulations Affect your strategic marketing plan. The EU is no longer the market where medical devices are launched first. Clinical study data is now required for all CE Marked devices. You need clinical data. Learn how to obtain that data from your US customers on May 1st at the CE Marking Workshop in San Diego at 10x: http://medicaldeviceevents.com/.
Despite the lack of design controls for Class 1 devices, manufacturers must still maintain a procedure for design transfer, maintain an approved device master file with all the approved design specifications (i.e., design outputs) and design changes may still require revalidation prior to implementation.
Class 1 devices are simple devices that are already on the market and have a history of clinical safety. Class 2 devices are generally more complex and present a moderate risk. Therefore, changes in the technological characteristics often present a greater risk for Class 2 devices. When you design a Class 1 device, you still have to determine what your design specifications will be, but you don’t need: 1) to review and approve design inputs, 2) a procedure to document your design process, 3) to document formal design reviews, and 4) to create a design plan.
In the 1997 guidance document for design controls, the FDA states that a design transfer procedure should include at least three basic elements. The first of these basic elements (i.e., design and development procedures) is not required for Class 1 devices, because product specifications for most Class 1 devices are simple. The other two requirements are basic principles of document control and configuration management. Therefore, you still need a design transfer procedure for Class 1 devices but you don’t need to include the first element that relies upon design and development procedures.
If you have a Class 1 device, you must still comply with labeling requirements (i.e., 21 CFR 820.120). If your device is sterile, you must still validate and re-validate the process in accordance with 21 CFR 820.75. Class 1 products also require, a device master record (DMR) in accordance with 21 CFR 820.181.
Although you do not technically have to have a DHF for a Class 1 products, the difference between the two categories is the following elements: 1) Design Control Procedure, 2) Design Plan, 3) Approved Design Inputs, and 4) Evidence of at least 1 Design Review.
If you are interested in learning more about design history files (DHF), please read this week’s blog: http://www.medicaldeviceacademy.com/blog/.
Next 510(k) workshop is April 18 in Chicago: http://medicaldeviceacademy.com/chicago-510k-workshop/.
It's a huge change to be got through in 3 years against the backdrop of ISO 13485:2016 and MDSAP transitions going on at the same time.
Are we going to see a reversal of fortunes, as Europe gets more difficult than US FDA?
See http://brandwoodbiomedical.com/almost-there-final-text-of-european-medical-device-regulation-is-published/ for a more detailed look at the changes.
Almost there… Final Text of European Medical Device Regulation is published
The Final text of the long anticipated European Medical Device Regulations has been published. The new regulations include some 123 Articles spit into Ten Chapters and Seventeen Annexes. It’s a weighty read, at some 566 pages compared to the 95...
First, the submission content and format requirements are the same. There are still 20 sections, and you use the same templates for either type of submission. At least a dozen forms are identical:
1. User fee (FDA Form 3601)
2. Table of contents
3. Cover sheet (FDA Form 3514)
4. Cover letter
5. Confidentiality certification
6. Indications for use (FDA Form 3881)
7. 510(k) summary
8. Truthful and accuracy statement
9. Class III summary
10. Financial certification
11. Declaration of conformity (FDA Form 3654)
12. Executive Summary
The differences between the two types of 510(k) submissions are also very predictable. The most significant difference is related to section 20--clinical performance testing. For a medical device, typically this section is not applicable. Only 10-15% of 510(k) submissions typically include a human clinical study. However, IVD products require clinical studies for 100% of submissions. IVD studies are different, because the study involves specimens--not human subjects. The specimen might be saliva, blood or plasma; but you still need clinical data to demonstrate efficacy of your diagnostic test.
There are specific questions in 510(k) RTA checklists for IVD products as well--regardless of which type of 510(k) submission you are working on. If you are making changes to an existing in IVD product, there are also specific questions in the FDA guidance documents for IVD products to help you determine if a 510(k) submission is required for your device modification.
If you are interested in learning more about IVD 510(k) submissions, there will be a webinar this Friday at 10am EDT: http://medicaldeviceacademy.com/ivd-510k-webinar/.
You can also watch the free webinar on 510(k) submissions in general that was hosted by Joe Hage: http://www.medicaldevicesgroup.net/webinar/510k-tips/.
The challenges of getting innovative medical device products out to market are subject to major regulatory audits that take a lot of time and money for the manufacturers. With software being a medical device in its own right when it falls under the definition of a medical device, the medical device software developers have to adhere to the same regulatory requirements as large medical devices do. This means FDA approval for companies placing their products to market in the USA and CE mark for the EU. The path to approval is both time-consuming as well as costly with the average of 77% of a medical device budget required for regulatory compliance in the US. With the majority of innovation stemming from small firms, the ability to maintain the competitive position and to produce technologies to address the needs of patients is put at risk.
By the time that all the required standards are implemented in and regulatory audits are passed by a medical device company, the competition for innovative medical software products might already have increased and the window of opportunity might be closing quickly. It takes more than half a year to implement one standard alone on the path to compliance.
Question for discussin: There is no doubt that the manufacturer has breached the local act and should be punished for that. But what about validity of the clinical evidence?
a) Do you think that the original clinical data (assuming that scientifically and ethically correct) is not valid?
b) Do you think that other clinical data obtained during PMCF is also not valid?
c) Is there any precedent in EU, how competent authorities are solving such issues?
Thanks for your ideas. I believe that someone may have experience with such manufacturer`s fault to share for interesting discussion within the group :-)
Does anyone know what is the meaning of "no additional cost" in COMMISSION REGULATION (EU) No 207/2012?
Is it including phone bill which make manufacturer should have free-toll number in each country?
can someone share how you deal with electronic IFU?
Medical devices can be purely hardware based (eg stethoscopes), be composed of hardware and software (eg patient monitor) or purely software (eg mobile medical apps).
In both the US and the EU, standalone software, such as a mobile app, can be a medical device in its own right if it has a medical purpose. This software may operate on a general purpose platform such as a smartphone and typically falls under the jurisdiction of a medical device regulatory authority. Such software is generally called Software as a Medical Device or SaMD.
1. What is Software as a Medical Device (SaMD)?
Software as a medical device (SaMD) is software that’s intended to be used for a medical purpose and that performs this function without being part of a hardware medical device, i.e. it runs on general purpose (non-medical purpose) computing platforms. For example, mobile apps that meet this definition are considered SaMD.
2. How do you determine if your software is a medical device?
This can vary depending on the country of sale, but in most jurisdictions (US, EU), the software is a medical device if the manufacturer (the person who legally markets the product) intends it to be used for a medically related purpose.
In other words, your software is a medical device when its intended use falls under the definition of a medical device.
The intended use is reflected in the specifications, instructions and information provided by the device (software) manufacturer.
Why You Should Hire For Potential, Not Experience
When you're hiring, look past the experience candidates come with, to the potential for them to grow into the perfect fit for your company.
What's the content of your DoCs?
According to the EU Official Journal published in 2008, the required content are:
"1. No xxxxxx (unique identification of the product):
2.Name and address of the manufacturer and/or his authorised representative:
3.This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):
4.Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate):
5.The object of the declaration described above is in conformity with the relevant Community harmonisation legislation: ………
6.References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared:
7.Where applicable, the notified body ... (name, number)… performed … (description of intervention) … and issued the certificate: ….
Signed for and on behalf of: ………………………….
(place and date of issue)
(name, function) (signature)"
I'm particular interested in knowing whether or not one can avoid Point 6 "References to the relevant harmonized standards used or references....."?
In my relatively short career within RA, I've never seen a DoC that contains a list of harmonized standards as this would require too much maintenance. The DoC format that i'm used to only contains references to applied Directives/Regulations and so far none of the notified bodies involved have commented this.
What's your experience?
I typically recommend submitting a pre-submission request before you have a “design freeze,” but I haven’t thought much about the question, “When is too early?”
Typically I am struggling to get everything complete before a 510(k) submission. However, for pre-submission meetings everything does not need to be complete. In fact, you can continue to submit additional updates to documentation after the FDA receives the pre-submission meeting request. As long as the FDA receives the documentation at least 2 weeks before the meeting the FDA will review your information.
To answer the question of when is too early, I pulled up the diagram of the design control process that I use for training courses. The diagram shows a stage-gate development process, but it also indicates when the risk management activities should be scheduled relative to design activities. I started to redraw the diagram so it was larger, and then I added the various milestones of the 510(k) process. Working backwards...
The 510(k) clearance occurs at the very end of the design process and that’s when the DHF is “closed.”
The 510(k) submission occurs at the end of design verification and validation--assuming you have been preparing the submission in parallel with V&V testing.
The 510(k) preparation begins just after V&V testing begins, because it typically takes about 14 weeks to complete the testing and the 510(k) can easily be prepared in parallel with V&V testing if you devote about 4 hours a week to the preparation.
The pre-sub meeting should take place before the approval of the design outputs (i.e., “design freeze”).
The pre-sub meeting request should be submitted 75-90 days before the target date for your meeting with the FDA. On my diagram that date is approximately around the same time that design inputs are reviewed and approved.
After seeing when the approximate time of the pre-sub meeting request submission, I realized that you can’t really submit a pre-sub request until you have identified the critical design inputs. Therefore, once you have performed a preliminary hazard identification and developed a testing plan, you should be able to review and approve you design inputs. This is really the earliest point for asking the FDA questions.
You also have to keep in mind that the FDAs answers might force to change you design inputs.
If you are interested in receiving a copy of the diagram I described above, please send me an email request at firstname.lastname@example.org. If you are already subscribed to my 510k-tips email list, you should already have an email with this diagram included. You might also be interested in my new blog about how to determine if you can submit an abbreviated 510(k) to save 30 days from your next submission: https://fdaecopy.com/abbreviated-510k/.
3D medtech printing under EU Medical Devices Directive and under future Medical Devices Regulation
3D medtech printing conference maastricht presentation discussing 3D medtech printing under EU Medical Devices Directive and under future Medical Devices Regulation
Additionally, the recommendation emphazises that not just manufacturers but also suppliers need to be put under scrutiny. But I have not heard of this "second level" auditing process.
Can anyone in the group recommend reliable sources of information, or share any data on this topic?
Does anyone have any advice? Where should the "baseline" be set? Is there a formulaic answer?
This becomes a struggle between the pessimists of Quality and the defensiveness of Design. (I've been both, so I try to sympathize...)
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With the changing face of education in many sectors to online education courses I wonder how many people or companies are changing or are thinking of changing to this form of education.
In 2015 online education was a 105 billion dollar market which is predicted to grow to 244 billion dollars by 2022.
What are the advantages of online education?
- You determine when and where to study the courses. No travelling to training centres or paying for trainers to come to you.
- Immediate results and feedback throughout the course.
- In many cases, this results in a more effective learning experience.
- Courses usually come a lot cheaper than standard classroom delivered courses.
- Courses can be tailored to specific industry needs.
But are the courses which you require available?
Yes, there are many providers of this type of education, certainly for regulatory affairs and ISO standards. However, when it comes to education for those medical device manufacturers using ERP systems I do not see ERP courses readily available. They are provided by either external or internal generic courses in most cases.
This where I would like to ask for your help.
I would like to see what the demand for this type of course would be in the medical industry for manufacturers using Oracle eBusiness Suite (EBS) R12, in particular, but not limited to, quality results data collection using the Quality module.
Could I please ask you to answer three simple questions, yes or no. Obviously any other comments you may care to offer would be welcome.
1. Does your company use Oracle EBS R12?
2. If yes, do they use the Quality module or would they consider using it?
3. If an online education for "Quality Data Collection using Oracle EBS R12 Specifcally for the Medical Devices Industry" was available, would you be interested in taking the course?
Thanks in advance for your assistance in this short survey.
The latest update is that manufacturers will be responsible for updating the Eudamed database in the future as part of the new European Regulations. This requirement will be implemented during the next years. The database will also become accessible to the public.
The primary publicly accessible database for adverse event reporting is the US FDA MAUDE database:
The MAUDE database is also integrated with other FDA databases for 510k submissions and recalls. This combined database is called the Total Product Life Cycle database:
The Therapeutic Good Administration (TGA) in Australia makes adverse event data publicly available:
The TGA also has a national registry for implanted orthopedic devices that publishes an annual report. There are other countries that also have public registries.
Searching for post-market surveillance data should be performed on a frequency that is risk-based. If you have a brand new device, a high risk device or a device that is implanted; post-market surveillance data should be reviewed frequently--either monthly or quarterly. In fact, the new European guidance document for clinical evaluation reports (MEDDEV 2.7/1 rev 4) requires that clinical evaluation reports be updated at least annually for these devices:
It is also important that you collect post-market surveillance data for both your device and competitor products. Therefore, you should be reviewing all the publicly available adverse event databases. You should also be reviewing your own complaint data, and you should be searching for journal articles that may include adverse event data--possibly associated with a clinical study.
If you are interested in the full text of this article and future articles, please visit my blog page: