The, for quite some time awaited, new version of DIN EN ISO 13485 has now come out. It differs in many respects from the previous standard. Therefore, changes of your existing quality system will become necessary. It is expected that this version of EN ISO 13485 will be harmonized within the EU. The transition period is expected to end on March 31, 2019.
An essential aspect of the new standard is a significantly extension of the risk-management to almost all processes. These include now, software validation, demonstration of effectiveness of training, and the requirement to link post-market-surveillance and risk management.
It can be noticed that this new standard comes closer to the US regulations. So, now a Development File is required in analogy to the US Design History File. For manufactured devices or batches thereof, records like a US Device History Record will be required. Companies already in compliance with US regulations will benefit from these regulations.
Other new regulations are related to data protection of individual health data, more stringent requirements for validations, measures for non-compliance of purchase criteria, identification and product status during production and control of non-conforming products.
With pleasure we can advise you on these issues and assist you in implementing the new standard.
Please contact us:
YES Medical Device Services GmbH, Phone: +49-6172-76464-890, firstname.lastname@example.org