Designing a ISO 13485 - Compliant Quality Management System

Client


Kestrel BioSciences, LLC

Situation

The client performs contract design, development and manufacturing of immunoassays for manufacturers of in vitro diagnostic medical devices. In order to satisfy existing customer requests, attract more clients and grow the business, the client decided to pursue certification to the international standard for quality systems for medical devices (ISO 13485:2003). This is an expensive, lengthy and complex endeavor that typically takes a year or more and requires an investment in the tens of thousands of dollars.

Actions

I started the project at the end of March 2014 with a project plan and outline of the documentation requirements. I solicited bids from the various registrars (e.g., TUV, BSi) and established a budget. Over the next 4 months, I partnered with the senior operations manager to draft the entire quality system documentation in preparation for a pre-assessment audit conducted in July 2014. The Stage 1 assessment audit was conducted in August; the Stage 2 assessment audit was conducted in September. Minor nonconformances were addressed through a corrective action plan submitted to the registrar for approval.

Results

The client received its certificate of registration to the standard from BSi on October 16, 2014 - only 6 months after we started the project.

FDA 510(k) NSE Decision is Remediated

Client


IVD Research, Inc.

Situation

The client - a manufacturer of in vitro diagnostic medical devices - contacted me in a state of frustration after having received a "Not Substantially Equivalent (NSE)" letter from FDA for a 510(k) submission for the company's test for Giardia. The client was eager to market the test and realize revenue growth for the business.

Actions

I reviewed the original 510(k) submission and the complete FDA correspondence and determined that an important reproducibility study was lacking in the original submission. I worked with the manufacturer's clinical collaborator to design a new study. I worked with the FDA Lead Reviewer in the Division of Microbiology Devices to resolve the other deficiencies noted by FDA in the NSE Letter.

Results

The new 510(k) was submitted to FDA, resulting in market clearance for the test less than 8 months after the original submission was rejected.

Print Print | Sitemap
© FDA Consulting, LLC