ENSURING QUALITY MEDICAL DEVICES MEET REGULATORY SCRUTINY IN THE FACE OF INDUSTRY COST PRESSURE – (PPT)

摘要

Newer regulations driving cost. Unannounced notified body audits – commission recommendation 2013/473/EU: This is not granting new authority, but there are many new concepts, Frequency: Unannounced audits should be performed at least once every three years with the potential to flow down to critical suppliers, Costs: Costs are paid by the legal device manufacturer, Subcontractor: Critical subcontractors and suppliers must be provided to your notified body, Scope: These are product audits, quality management audits will continue.