ISO 13485:2016

ISO 13485:2016: What are the differences? ISO 13485:2016 introduces changes in comparison to the previous versions of the standard. Thereby ISO 13485 became even closer to the requirements under 21 CFR part 820 (Quality System Regulations). Unfortunately, it will be...

MDSAP

MDSAP: Medical Device Single Audit Program The Medical Device Single Audit Program (MDSAP) was initiated to satisfy a wish of many medical device manufacturers: To replace the various audits and inspections by authorities with one standardized audit.  Fig. 1: The...

Document Control

Document release – is the four-eyes principle necessary? An efficient document release procedure is one of the most important prerequisites for an effective quality management system. This article will explain how you can improve your team’s productivity...

CSV

Computerized System Validation CSV Authorities and notified bodies increasingly address the Computerized System Validation (CSV) in audits. This article introduces regulations regarding “Computer System Validation” and provides guidance on how you can best...

Audits

Audit: Prerequisite for ISO 13485 Certification In most cases, an audit by a notified body is a prerequisite to market medical devices in the American market. Definitions Definition: Audit „Systematic, independent and documented process for obtaining audit evidence...