SGS are conducting a webinar on 23 November, titled as below:
ISO 13485:2016 The Journey to Regulatory Compliance for IVD Medical Device Manufacturers Webinar
With the significant regulatory changes underway for market access to the EU, IVD medical device manufacturers need to be aware that the compliance requirements that they face for the new EU IVD Regulation are changing dramatically. Under the current EU Directive, only about 20% of the higher risk IVD devices require Notified Body certification, but this will change to an estimated 80% of all devices under the new EU IVDR. Reaching that compliance goal is a difficult journey and a significant first step will be to achieve accredited certification for their quality management system with ISO 13485:2016 as the dedicated medical device and IVD QMS standard.
Certification with this key QMS (ISO 13485) standard specifically applying to medical devices and IVD manufacturers is the first step on that regulatory compliance journey and lays the foundation for meeting your regulatory obligations.
Among those invited are manufacturers looking to get their quality management system certified for the first time. SGS are hoping to engage with the forward thinkers who are preparing for the new EU IVD Regulations (IVDR) before they become mandatory next year.
The link to the registration page can be found here.