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.
FDA Approval of Your Medical Devices: There’s No Escaping It, Might as Well Accept It
Acceptance: The Fifth Stage of Regulatory Grief (video) Let’s face it – no one likes being told what to do,
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FDA Medical Device Classification and the “Simple” Surgical Mask
As I have said before, there is nothing simple about a surgical mask. And now many companies seeking to manufacture
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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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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:
