Question
In addition to the qualification requirements for clinical evaluators (prescribed in section 6.4 of MEDDEV 2.7.1 rev 4 which was published June 29, 2016), each of the evaluators must provide a detailed “Declaration of Interest” detailing all relevant...
Acceptance sampling is a technique often used in verification of product. The sampling methods depend on either variables or attributes. Most device companies used published documents such as Z1.4, c=0, or Z1.9. There are other methods, although not ...
Goodmorning all, I have a question about the use of the IVD symbol on in vitro diagnostic products in USA. The IVD symbol as defined in ISO 15223 standard should be used to indicate "a medical device that is intended to be used as an in vitro diagnos...
The most common way to answer this question is with a question.How long is a review supposed to take? orHow long does a review actually take?Most people want to know the answer to the second question, and they want real data to back it up. Therefore,...
Our product received CE certification. In addition to the product labels and IFU, We would like to indicate in our product' catalogue the CE Marking with N.B number. Is it allowed? Please explain/Make citation.Thank you.source: https://www.linkedin.c...
Dr Fatima Zaid Abu Zanat
Regional Regulatory Affairs & Scientific Office Manager at Mundipharma International Limited
January 2016
Hi Colleagues!Does anyone have the medical device regulations/ guidelines for West Africa (Ivory Coast, Senegal, Mali, Cameroon, and Gabon)?How long does it approximately take to complete the registration process especially for Class IIb and III medi...
Earlier today I received the following question via LinkedIn: For verification and validation test records, are signatures needed?The person that asked the question thought the answer should be “Yes,” but is it required?This person read through the F...
Jedrzej Kocinski
Assistan Professor (dr hab.) w Uniwersytet im. Adama Mickiewicza w Poznaniu
February 2017
As far as I know it is not obligatory to have one to get 510(k) cleared in FDA. There are no medical devices on OSHA list. However most of the people say that it is necessary in practice, because hospitals and other institutions do not want to use d...
Don’t ever believe what you hear. Instead, look it up. I think the software requirements are minimal in the newly released ISO 13485:2016 standard, but other experts disagree. In the QSR, software is also covered, and regulatory requirements are incl...
This particular question seems to be a common nonconformity during audits. There are three reasons for this:the question is on several regulatory checklists for certification bodies,training on regulatory requirements is seldom provided to design eng...