ISO 13485 Made Simple: Using Risk to Guide Your Quality System ISO 13485 requires that medical device companies use a risk-based approach in their quality systems. That means the more risk something poses to product safety or compliance, the more carefully it needs to...
How to Complete FDA Annual Facility Registration: A Step-by-Step Overview This video highlights the step-by-step process for completing the FDA annual facility registration, a mandatory requirement for medical device businesses operating under FDA jurisdiction. The...
Are Supplier Audits Required? No Neither ISO 13485 nor FDA 21 CFR explicitly require supplier audits, although supplier audits are one mechanism of qualification. The requirements established in FDA and ISO rules are: • Companies must define evaluation and selection...