ISO 13485:2016 – Putting off compliance until the last minute could cost you dearly

By Stewart Eisenhart, Emergo Group This is part one in a series of blog posts Emergo will be publishing during 2016 discussing the rollout of ISO 13485:2016 and how companies can prepare.  Now that the highly anticipated update to the ISO 13485 quality management system standard has been published, medical device manufacturers have a three-year transition period to come into compliance with the new version of the standard. That’s a long time right? Don’t be so sure. Although the ISO 13485:2016 compliance deadline is not imminent, advance planning is essential to avoid panic closer to March 2019. The primary reason you should not wait too long is that European Notified Bodies are busy—really busy. Since 2013, Notified Bodies have been obliged to conduct random compliance audits of manufacturers at least once every three years. This has created a massive amount of additional work for Notified Bodies. Add to this the fact that ever since the PIP breast implant scandal, NBs are under much more scrutiny from Competent Authorities. This has led to some of the weaker NBs pulling out of the market and also created a massive resource problem for the NBs. They simply do not have enough auditors to do all the work. Unfortunately for device manufacturers, this means you will likely be paying higher prices and waiting longer periods of time for Technical Files reviews and certification audits. Thus, if you think you can wait until mid- to late 2018 to get ready and schedule your r...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Blog Emergo Group Source Type: news