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    Alan Farthing
    Regulatory Manager at Solent Group
    April 2014
    Can anyone on here help me understand how toothpaste and mouthwash can be Medical Devices?
    There are a few such products on the UK market that (from the CE mark and Notified Body number) are Class II devices. They are for sensitive teeth and I can almost understand how they could be pharmaceutical products since they have an active and spe...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    August 2019
    How do you set the right price for your new device?
    I begin this conversation with a question: Which factor have you found to be most important in terms of setting a purchase price for a successful market launch: Hospital bundling, a desire on the part of the surgical/medical staff for the device, or ...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    July 2019
    The time-buying MDR trick you need to hear immediately
    I stumbled upon a significant idea with regulatory and quality expert Michelle Lott last week. Seize it immediately! Here's that 9-minute conversation. Get or renew your CE mark TODAY! If you prefer reading, the conversation highlights are: Get or re...
    Dan O'Leary
    President at Ombu Enterprises, LLC
    May 2015
    Design verification and sample size
    Often I see companies performing design verification by manufacturing components, subassemblies, etc. and performing inspections and tests. In these instances, it appears to me that some device manufacturers have conflated design verification with ma...
    Luisa Mella
    Strumenti medicali
    November 2015
    Use of RUO and IUO labeling
    Dear all, I have a question about RUO and IUO labeling in US market.According to FDA guidance "Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only": RUO product is an IVD product that is in the labor...
    Rob Packard
    Ship & Print Your FDA eCopy
    February 2017
    Where you can find adverse event data for your device
    Most countries have some kind of database for gathering adverse event data for medical devices, but most of these databases are not open to the public. The most common question I am asked is, “How do you access the Eudamed database?” for reporting of...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    February 2017
    Breaking Into the Medical Device Sales Industry
    As leader of the Medical Devices Group, I get asked multiple times per week by medical device sales candidates how they can break in to the medical device sales industry. I wish I had an easy answer, definitive resource, or job for them. I don't. But...
    Michael Alper
    CEO at Wallaby Medical
    June 2016
    Country of Origin Requirements
    I'm trying to understand which countries' regulatory bodies have country of origin requirements and what does "country of origin" actually mean for these countries. Which countries have "country of origin" approval requirement for medical devices?If ...
    Elizabeth Doyle
    Mechanical Engineer excited to design and manufacture medical devices and assistive technologies.
    March 2018
    Biocompatible materials
    I've been trying to find a list of materials approved for implant by the FDA with little luck. Can anyone point me towards such a list? Or do you have a personal list compiled over the years that I could use as a reference point? Application-wise, ri...
    Sabrina Dessources
    Senior Manager Regulatory Affairs-CMC at Alexion Pharmaceuticals, Inc.
    August 2015
    ISO standards versus EN ISO standards
    Good morning everyone, I need some advice please! Hopefully someone can shed some light! The company manufactures IVD devices, and the QMS is currently in conformity with BS EN ISO 13485 (and all other applicable EN ISO Standards). Because we will al...
    « Previous 1 2 3 4 … 99 Next »

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