Regulatory affairs for medical device startups

February 13, 2015 by Andrew Ahn

Instilling a robust quality management system as soon as possible is crucial in becoming a successful medical device company, writes Regdy blog’s Andrew Ahn.

Here’s a common short-sighted view that many medical device startups have:

The 510(k) submission is the End-All-Be-All

I get it…the founders of Tech Startups are usually new to medical device requirements and they hear that they need to put together a 510(k) submission dossier to get their product approved by the Regulatory Body and BAM they are good to go. But hold your horses, you’re talking about building a house, when you haven’t laid down the foundation…cuz let me tell ya’, there are going to be some earthquakes and inspections ahead.

Instilling a robust Quality Management System (QMS) as soon as possible is crucial in becoming a successful medical device company

For me it begins from the top. Top Management must look at the existing staff and be able to designate Roles and Responsibilities in light of the QMS. The organizational chart shows who are the subject matter experts, but we need to substantiate their qualification (i.e. Training Records) to execute their job properly. This can be more challenging for Startups because resources are limited and employees often wear many hats. But let me ask you this, would you rather fly on an airplane operated by a licensed pilot or by a Fedex driver?

Only once the roles are established and appropriate training is provided can you have a document control system. If you don’t know who is qualified to do what, then how do we know who should create what document and who should approve those documents?


Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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