In your quest for a compliant, safe and effective Medical Device, a certified Quality Management System (QMS) is not only a key step along the way, but also a regulatory requirement. The implementation of a QMS, however, can be a tricky thing to navigate, with many organisations not even knowing where to start. NCISS and our dedicated Quality Team have all been trained to various levels of ISO 13485, as well as having real-world experience with certified QMSs, and can help you begin your journey in a clear and structured manner. We offer:
- consultancy on how to get started with an ISO 13485 QMS
- input on specific documents within your QMS
- gap analyses
- internal or mock audits
