Regulatory affairs advice for medical device startups |

Regulatory affairs advice for medical device startups

regulatory 2Regulatory affairs for medical device startups (MassDevice)

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?

Document Control is the foundation of your quality system. The purpose of a Document Control System is to:

  • Ensure that the responsible persons are trained and training records are maintained.
  • Designate the appropriate personnel(s) who are required to author/approve documents or execute a given task (i.e. testing).
  • Instruct how employees do things (Procedures)
  • Save a lot of time in the long run when it runs like a well oiled machine and you are able to quickly identify what you need and revise the documents in a systemic fashion.
  • Design Controls, ensure that the procedures, templates and test reports produce consistent and accurate depiction of the device and the units perform as intended.
  • Manage complaints – what are the users experiencing? Are there adverse events that indicates a malfunction of the device?
  • CYA & SYA (Cover Your Ass and Substantiate Your Actions).
  • Everything is traceable via documentation to a root cause.

This only scratches the surface of the importance in establishing a robust QMS but as you can see, quality is instilled in the process…a process which is manifested via documents…documents that will go into your 510(k) for submission…a 510(k) that allows your product to be born into the outside world.

Having a strong QMS foundation will not only help you with your 510(k), but will pay dividends after you launch the product…reduced malfunctions, better audit results, easier access to other countries and most importantly, a safe and effect device that makes users happy and coming back for more.

Andrew Ahn’s Regdy blog provides unique insights and actionable tips from within the Health Tech industry.
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