Medical Devices require regulatory approval before they can be sold to doctors and patients. In the US, this review is performed by the Food and Drug Administration, while Europe uses private companies under government oversight. In either case, the goal is to check that the products are safe and effective for their intended use, and to ensure that manufacture produces product of consistently high quality.
Europe operates under an EU Medical Devices Directive, which requires countries to set up panels of experts to establish rules and test procedures for every type of medical device. These Competent Authorities, the MHRA in the UK, approve companies, the Notified Bodies, who apply the rules and approve devices for use. The approval itself is a registered CE mark, which is applied to conforming product.
Thus, passing through the approvals process is the major gate standing between development and revenue.
The gate is opened by passing three audits: one for organizing and documenting manufacture appropriately, one for operating manufacture appropriately, and one for providing evidence that the product is safe and effective. We have been configuring and documenting our manufacture during the past two months, ‘Establishing an ISO –Compliant 13485 Quality System’ in the industry jargon.
It is a very detailed and tedious process: we have 22 central Standard Procedures that have to be written and reviewed, nearly 100 Forms, and lots of supplemental pieces like meeting minutes, IT support, job descriptions, problem reports, training records, and company policies.
Four of us have worked all day, every day for the past two months to get this all set up in anticipation of our first audit by our Notified Body today.
Establishing a Quality System normal takes 6 months to a year, but we are trying to do it much more quickly: funds, licenses, and rule changes would be deadly for the startup if things lingered on that long.
A scientist / entrepreneur / free-thinker, I have long struggled with documentation, compliance, and audit conformance in corporate environments: it is too many limits and too much pedantic detail. Thus, it’s both ironic and frightening that I have to set up my own system and be tested on it.
So, the audit was today and….We Passed! (‘actual photo of audit in process, above)
We had a couple of minor non-conformances (goals need to be measureable; auditors need to be impartial) and three majors (two for meetings that need to be held and one for selecting a sterilization vendor), all easily fixed.
Our Clean room will be installed on Monday, and we will begin producing product samples for testing in the following weeks. But this is a big deal and a huge step forward towards creating a revenue-generating and profitable company.