Willy Wonka and the Chocolate Factory was one of my favorite movies when I was a kid - all that chocolate! All that candy! Heaven on earth to a seven-year-old, even without the Golden Ticket.
But have you ever noticed just how many quotes from the movie can apply to regulatory affairs?
For example, when a regulatory consultant tries to explain FDA requirements to a client, they may say "𝘙𝘶𝘭𝘦𝘴? 𝘞𝘩𝘢𝘵 𝘳𝘶𝘭𝘦𝘴? 𝘞𝘦 𝘥𝘪𝘥𝘯'𝘵 𝘴𝘦𝘦 𝘢𝘯𝘺 𝘳𝘶𝘭𝘦𝘴, 𝘥𝘪𝘥 𝘸𝘦 𝘊𝘩𝘢𝘳𝘭𝘪𝘦?"
To which the regulatory consultant typically replies "𝘠𝘰𝘶 𝘭𝘰𝘴𝘦! 𝘎𝘰𝘰𝘥 𝘥𝘢𝘺, 𝘴𝘪𝘳"
When trying to explain the latest clarity-challenged missive from the FDA, you can simply say "𝘠𝘰𝘶 𝘴𝘩𝘰𝘶𝘭𝘥 𝘯𝘦𝘷𝘦𝘳 𝘥𝘰𝘶𝘣𝘵 𝘸𝘩𝘢𝘵 𝘯𝘰 𝘰𝘯𝘦 𝘪𝘴 𝘴𝘶𝘳𝘦 𝘢𝘣𝘰𝘶𝘵."
Or when your client threatens to submit a 510(k) submission without a comprehensive quality management system in place? "𝘗𝘭𝘦𝘢𝘴𝘦 𝘥𝘰𝘯'𝘵 𝘥𝘰 𝘵𝘩𝘢𝘵 - 𝘐 𝘣𝘦𝘨 𝘺𝘰𝘶."
When you go onsite for an internal audit and the client tries to justify the gaps in their documentation, you can flick your hand in their direction, saying ""𝘕𝘰, 𝘯𝘰, 𝘥𝘰𝘯’𝘵 𝘴𝘱𝘦𝘢𝘬. 𝘍𝘰𝘳 𝘴𝘰𝘮𝘦 𝘮𝘰𝘮𝘦𝘯𝘵𝘴 𝘪𝘯 𝘭𝘪𝘧𝘦, 𝘵𝘩𝘦𝘳𝘦 𝘢𝘳𝘦 𝘯𝘰 𝘸𝘰𝘳𝘥𝘴. 𝘙𝘶𝘯 𝘢𝘭𝘰𝘯𝘨 𝘯𝘰𝘸."
You may even be pleasantly surprised to find "𝘓𝘪𝘵𝘵𝘭𝘦 𝘴𝘶𝘳𝘱𝘳𝘪𝘴𝘦𝘴 𝘢𝘳𝘰𝘶𝘯𝘥 𝘦𝘷𝘦𝘳𝘺 𝘤𝘰𝘳𝘯𝘦𝘳, 𝘣𝘶𝘵 𝘯𝘰𝘵𝘩𝘪𝘯𝘨 𝘥𝘢𝘯𝘨𝘦𝘳𝘰𝘶𝘴" when reviewing said documentation.
(It's rare, I grant you, but it does happen 😁)
Strangely enough, there are quotes that apply to MDR as well. The EC may have said this very thing while writing the original legislation: "𝘈 𝘭𝘪𝘵𝘵𝘭𝘦 𝘯𝘰𝘯𝘴𝘦𝘯𝘴𝘦 𝘯𝘰𝘸 𝘢𝘯𝘥 𝘵𝘩𝘦𝘯 𝘪𝘴 𝘳𝘦𝘭𝘪𝘴𝘩𝘦𝘥 𝘣𝘺 𝘵𝘩𝘦 𝘸𝘪𝘴𝘦𝘴𝘵 𝘮𝘦𝘯."
And now, when faced with questions from manufacturers trying to make sense of the complex regulation, I can almost hear the EC say "𝘖𝘧 𝘤𝘰𝘶𝘳𝘴𝘦, 𝘺𝘰𝘶 𝘥𝘰𝘯'𝘵 𝘬𝘯𝘰𝘸. 𝘠𝘰𝘶 𝘥𝘰𝘯'𝘵 𝘬𝘯𝘰𝘸 𝘣𝘦𝘤𝘢𝘶𝘴𝘦 𝘰𝘯𝘭𝘺 𝘐 𝘬𝘯𝘰𝘸. 𝘐𝘧 𝘺𝘰𝘶 𝘬𝘯𝘦𝘸 𝘢𝘯𝘥 𝘐 𝘥𝘪𝘥𝘯'𝘵, 𝘵𝘩𝘦𝘯 𝘺𝘰𝘶'𝘥 𝘣𝘦 𝘵𝘦𝘢𝘤𝘩𝘪𝘯𝘨 𝘮𝘦 𝘪𝘯𝘴𝘵𝘦𝘢𝘥 𝘰𝘧 𝘮𝘦 𝘵𝘦𝘢𝘤𝘩𝘪𝘯𝘨 𝘺𝘰𝘶 - 𝘢𝘯𝘥 𝘧𝘰𝘳 𝘢 𝘴𝘵𝘶𝘥𝘦𝘯𝘵 𝘵𝘰 𝘣𝘦 𝘵𝘦𝘢𝘤𝘩𝘪𝘯𝘨 𝘩𝘪𝘴 𝘵𝘦𝘢𝘤𝘩𝘦𝘳 𝘪𝘴 𝘱𝘳𝘦𝘴𝘶𝘮𝘱𝘵𝘶𝘰𝘶𝘴 𝘢𝘯𝘥 𝘳𝘶𝘥𝘦. 𝘋𝘰 𝘐 𝘮𝘢𝘬𝘦 𝘮𝘺𝘴𝘦𝘭𝘧 𝘤𝘭𝘦𝘢𝘳?"
And lastly, at the end of a long and tortuous day spent trying to persuade a resistant client that design validation is not the same thing as design verification, and that they still have testing to do before they can event think of going to the FDA, as you walk wearily to your rental car and head back to the hotel for a restorative glass of wine, you can tell yourself “𝘚𝘰 𝘴𝘩𝘪𝘯𝘦𝘴 𝘢 𝘨𝘰𝘰𝘥 𝘥𝘦𝘦𝘥 𝘪𝘯 𝘢 𝘸𝘦𝘢𝘳𝘺 𝘸𝘰𝘳𝘭𝘥.”
#medicaldevices #regulatoryaffairs #compliance #FDA #qualitymanagament #medtech #biotech #eumdr #europe
Digital Product Lead Web Developer Shopify / Shopify plus E-commerce
1moJosh Kumpf