I am pretty thick-skinned and not easily flustered. But few things get me as agitated as the ongoing debate over MDD versus MDR.
As I explain in this clip, MDR is NOT replacing MDD, it is ADDING to it. The MDD regulations are NOT going away once MDR is implemented. Medical device companies do NOT have to reinvent the regulatory wheel. A few simple changes will ensure alignment with the new regulations.
The Do’s and Don’ts of FDA Submission Pathways
As a certified regulatory grief counselor, I am asked about FDA submission pathways all the time. These questions typically come
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FDA regulations and your bottom line
FDA regulations change constantly. Know the changes, because being compliant means able to sell. And ‘able to sell’ means cash flow.
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Choosing the Right FDA Pathway for Your Product, Component or Accessory
Choosing the right FDA pathway for your product is not easy and can be fraught with regulatory landmines. But by
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Michelle Lott and the leanTeam help clients recognize regulatory and quality issues aren't a "burden" – they are strategic advantages when used properly. The expert team will also strip away any redundant or misdirected activities so you can focus on what really matters:
