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...
Medical Device Benefit-Risk Analysis: Process & Best Practices
Medical device benefit-risk analysis is a structured evaluation of whether the clinical benefits of a device outweigh its residual risks. It is mandated under ISO 14971:2019, FDA regulations, and EU MDR. Thus, it is critical for regulatory approval, patient safety,...
9-Step Guide to FDA Design and Development Planning
FDA design and development planning is a structured process mandated under 21 CFR Part 820 (Quality System Regulation). It serves as the mandated roadmap for controlling a medical device’s progression from initial concept to a validated product. It ensures...