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    Tautvydas Kazlauskas
    Pharmacist AT EUROVAISTINĖ
    August 2018
    MD classification question
    Hello,How would you classify fibrin-glue like medical device? The intended purpose of the device is management of bleeding in traumas or surgical procedures (i.e endoscopy) IIb or III and why?
    Antonia Trevisan
    regulatory engineer presso Lima Corporate
    August 2018
    MDR: Are custom-made devices exempt from CE marking?
    I have a question on MDR implementation: Is it confirmed that custom-made devices are exempt from CE marking?According to MDR art.20 par.1, and art.52 par.8, I believe that custom-made devices are exempt from CE marking. Are there any conflicting int...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    August 2018
    510(k) was supposed to be the exception. "It's Regrettable."
    First, I have to say how liberating it is to be writing you on my own site versus LinkedIn. I literally feel a wave of relief washing over me. First, I don't have to count characters. Second, I've already used italics(!), something LinkedIn doesn't ...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    August 2018
    How to estimate safety BSE requirements?
    A subscriber (Irina) asks, "The TSE Risk estimation document (Germany, 1994), "Safety Requirements for Medical Products Derived from Body Constituents of Cattle, Sheep, or Goats to Avoid Risk of Transmission of BSE or Scrapie," requires an estimate o...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    July 2018
    How big a deal is FDA's Case for Quality?
    From the looks of things, pretty big. If you tuned into the first of FDA’s Case for Quality webinars, you learned about FDA’s shift their from 'compliance with regulations' to 'device quality.' Get the replay and register for part two at https://medg...
    Marcelo Antunes
    Regulatory affairs strategy consultant at SQR Consulting
    July 2018
    Revision of ISO 14971 - Medical Device Risk Management
    The DIS (Draft International Standard) of the review of ISO 14971 - Health Product Risk Management - should be circulated to national committees soon. The ballot will remain open until mid-October.It is extremely important for those involved to revie...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    July 2018
    Cloud-based QMS/PLM system
    I am looking for a cloud-based Quality management system with at minimum Document change management and Design control features. Any recommendations? source: https://www.linkedin.com/groups/78665/78665-6422825542688477185
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2018
    FDA's Case for Quality: What, Why, and How?
    Ooh, I've got a good one for you today: An FDA regulator is giving a special 90-minute webinar for Greenlight Guru and the Medical Devices Group. Shout out to Jon Speer for arranging. Your free registration at https://medgroup.biz/case-quality. Franc...
    Bradley Merrill Thompson, RAC
    Medical Device, Digital Health and Combination Product Regulatory Attorney
    June 2018
    FDA Precert program lacks legal authority
    FDA updates Pre-Cert program as it begins to grapple with ‘hard questions’New updates to the FDA's Software Pre-Cert working model shows the program is making significant gains, but FDA attorney Bradley Merrill Thompson tells FierceHealthcare the age...
    Christine Zomorodian
    Principal Consultant at Gish Consulting
    June 2018
    Investigating Root Cause
    One of the themes I come across regularly with my medical product manufacturing clients is uneven skills in investigation and determining root cause through a rigorous and adequate Root Cause Analysis (RCA). In some cases, it is newer team members wh...
    « Previous 1 … 3 4 5 6 7 … 26 Next »

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