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    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    July 2019
    The Innovation Every Ostomy Patient Needs
    God bless Michael Seres. He was diagnosed with Crohn’s disease, an incurable bowel condition, at age 12. His first surgery at 14, he's 25 further surgeries stronger, having weathered intestinal failure and two bouts of cancer. He's now awaiting a ste...
    Eyal Lerner, Ph.D., B.Pharm, ICQE
    Pharmaceutical Quality Consultant elc@eyallerner.info
    March 2018
    Was Theranos approved by CSM, FDA or both?
    I was not completely aware to Medicare & Medicaid Services (CMS) agency. It regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments and approve Laboratory Developed...
    Shrikant Kalegaonkar
    Quality Engineer
    April 2016
    Does ISO 14971 Require Preliminary Hazard Analysis (PHA)?
    Hello All: In ISO 14971 Medical Devices--Application of Risk Management to Medical Devices clause 4.3 is "Identification of Hazards." It requires the manufacturer to compile documentation of known and foreseeable hazards associated with the medical d...
    Anna Lisa Somera
    Start Up Mentor and Grant Consultant
    July 2015
    Using a contract manufacturer's QMS
    Someone told me that it's possible for a med device company to use their contract manufacturer's ENTIRE quality system as their own. He said since design and development is outsourced, his company could just use all of the manufacturer's procedures a...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    March 2019
    MDR labelling requirements -UDI
    As originally asked by
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    February 2019
    $350 worth of free advice about reimbursement
    "Hip, hip, hooray! There's a new CPT code! I'm going to get paid!" you gleefully exclaim. "No you're not," health economist Nic Anderson said in this exceptionally valuable $350 consultation. I'm sharing approved, redacted portions of our call (yours...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    January 2013
    ISO 13485 Certification registrar and NB fees and approval time
    As originally asked by Olufemi Adeoye. Can someone provide me with estimates on how much ISO 13485 registrar (CMDCAS for Canada) and EU notified bodies charge for certification as well as how long it takes; considering 1) Specification developer/Auth...
    Dan O'Leary
    President at Ombu Enterprises, LLC
    October 2016
    Acceptance Sampling for Medical Devices
    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 ...
    Luisa Mella
    Strumenti medicali
    February 2016
    Use of IVD symbol on labeling in USA
    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...
    Saurabh Dubey
    Regulatory Affairs & Quality System
    September 2018
    Help with 510(k), GTIN, and GUDID
    I'm based in India and would like to understand the overall regulatory workflow for medical device product development. What are the documents I need to create for entry into the US market? I've started on our 510(k). Do I need to have GTIN and GUDID...
    « Previous 1 … 4 5 6 7 8 … 99 Next »

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