ISO 13485 Consulting
In detail
The scope of ISO 13485:2016 runs from QMS design and documentation through internal audits and CAPA processes to risk management per ISO 14971 and regulatory compliance for global medical device markets (EU MDR, MDSAP, FDA). Within exactly that scope I have supported medical device companies for over nine years in building and maintaining robust Quality Management Systems. The focus stays on Quality Management for medical devices — deep, sector-specific expertise rather than generalist advice.
QMS Implementation
Building and structuring compliant Quality Management Systems from the ground up, tailored to ISO 13485 and ISO 9001 requirements.
Documentation & SOPs
Creating, reviewing, and maintaining all QMS documentation in line with regulatory standards and operational needs.
What is ISO 13485 and why does my company need it?
ISO 13485 is the international quality management standard specifically designed for the medical device industry. It sets out requirements for a QMS that ensures consistent design, development, production, and delivery of medical devices that are safe and effective. For most markets — including the EU (MDR), Canada (MDSAP), and Japan — ISO 13485 certification is a prerequisite for market access, not a nice-to-have.
How long does it take to implement an ISO 13485-compliant QMS?
It depends on the starting point. A company with no existing QMS infrastructure should expect 9–18 months to reach certification readiness. A company with an existing ISO 9001 system can typically transition in 4–9 months. The timeline is driven by the complexity of your product portfolio, the size of your organization, and how efficiently documentation and process gaps are addressed. Early involvement of an experienced consultant shortens this significantly.