Risk-based thinking is more than a buzzword, it is the foundation of a smart and effective QMS. This post shows how to apply risk-based thinking practically across audits, CAPAs, supplier management, and training, so you can prioritize what matters, avoid unnecessary compliance burdens, and become a true strategic partner.
Data Integrity Crackdown: FDA Tightens Oversight on Third-Party Lab Testing Medical device manufacturers received a serious wake-up call this year: the FDA is rejecting study data from two Chinese labs after uncovering widespread data integrity violations. FDA is...
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...
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...