7-Step Beginner’s Guide to Get ISO 13485 Certification
ISO 13485 certification is the internationally recognized accreditation for medical device companies. It demonstrates compliance with a robust Quality Management System (QMS) tailored to patient safety, regulatory requirements, and risk management. The certification...
How to Tailor MDSAP Audit Readiness Checklist for US Market?
The US FDA accepts MDSAP audits in lieu of routine inspections. Hence, a single MDSAP audit can demonstrate compliance with both ISO 13485:2016 and FDA’s Quality System Regulation (21 CFR Part 820). For manufacturers, this reduces the burden of undergoing separate FDA...
8 Key Differences Between MDSAP and ISO 13485 Certification
ISO 13485 is a global medical device quality management standard. On the other hand, MDSAP is a regulatory audit program built on ISO 13485 but extended to meet country‑specific requirements. Thus, ISO 13485 builds the QMS foundation whereas MDSAP verifies compliance...
US FDA 510(k) Review Process and Main Stages: A Guide
The FDA 510(k) review process is the most common pathway for bringing moderate-risk medical devices to the U.S. market. It is a structured pathway ensuring a medical device is substantially equivalent to a legally marketed predicate device before clearance. The...