ISO 14971 helps medical device manufacturers apply risk management principles. Risk management must continue throughout device life cycle. Compliance requirements vary by country
Class 1 devices are low-risk medical devices that do not support life. These devices are typically non-invasive and pose minimal patient risk. Examples include bandages, wheelchairs, stethoscopes, and surgical instruments
IVD devices are classified into A, B, C, and D based on intended purpose and risks. New classification system represents significant change from current directive. Manufacturers must identify applicable risk class, notified bodies verify for others
ICH Q10 guidelines introduced in 2008 as comprehensive QMS model. System supplements GMP requirements and complements ISO 9001. Aims to address high development costs and governance challenges
ASME U Stamp is a certification mark for pressure vessels. It certifies compliance with ASME Boiler and Pressure Vessel Code. Required for vessels with pressure greater than 15 psi
No such certificate exists in European legislation. CE-certificate is often misinterpreted as EC-certificate or EU Declaration of Conformity. EU-Type Examination Certificate is required only for specific medical devices