FDA Puts Positive Spin on 2020 Just over a year after COVID-19 put the world on hold, the powers that be have released a news brief in which the FDA pu... In category: Regulatory Quality
The Biologics License Application Timeline – A Long, Long Road If you think that getting a medical device onto market is a long and tedious process, be glad you don’t have to de... In category: Regulatory Quality
Supplier Criticality – What the #@%$ Does That Mean? Customers ask me all the time – “Michelle, I keep hearing this term – supplier criticality. What does ... In category: Regulatory Quality
Deregulation of Medical Devices: Say It Ain’t So! You KNOW your proposed deregulation of medical devices is a bad decision when even the device manufacturers ask you to... In category: FDA Approval LinkedIn
Medical Device Regulation and Ye Olde Snake-Oil Salesman Blame the snake-oil salesmen. It’s mostly their fault that we ended up with so much medical device regulation in t... In category: LinkedIn Regulatory Quality
Why You Need a Document Control Process Why do we need a document control process? Oh, if only I had a nickel for every time I’ve been asked that question... In category: LinkedIn Regulatory Quality
The Post-Brexit Medical Device Legislation is Here! Clear some space on your regulatory bookshelf! You’re going to need room for your copy of the UK’s newly-ado... In category: LinkedIn Regulatory Quality
FDA Submission Types, Costs and Timeframes – Which is Right for You? Very few days go by without someone asking me to explain the differences between FDA submission types. This most often c... In category: FDA Approval LinkedIn Regulatory Quality
FDA Submission for Combination Products How do you determine the correct FDA submission for combination products? What IS a combination product? A combination p... In category: FDA Approval LinkedIn Regulatory Quality
How to Help Overturn FDA’s Harmful Down-Classifications FDA made it easier to commercialize 91 risky medical devices. You can help reverse the ruling: 2 easy steps, 5 minutes. ... In category: Regulatory Quality
