In the realm of medical device development, a QMS should also ensure that processes align with ISO 13485 standards and US FDA 21 CFR 820 regulations, which is the backbone of our QMS at Design Concepts.
It is no secret that despite the obvious good intentions of a QMS that they can also get a bad rap for creating undesirable "paperwork" and processes that are viewed as slowing down progress and, in the worst cases, squelching innovation. It is that bad reputation that made the development of QMS for Design Concepts a critical initiative for us.
We needed a QMS that was thoughtfully developed, focused on value-add to the organization, and aligned with the requirements of ISO-13485 and the FDA. A key attribute for our QMS was it needed to ensure we had the flexibility to take on projects that fall outside of the medical device and healthcare realm.
Our solution was to create a tiered approach that allows our projects to be run under our QMS design controls or our clients as defined in the contract governing the work. This allows us to tailor our approach for individual client needs while ensuring that roles and responsibilities are defined and well understood.
The tiered system approach has provided us the flexibility we need.
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