ISO 13485: 2016 Requirements and Compliance to Latest Updates 2019 is a webinar dedicated to Key changes to the ISO 13485:2016.
ISO 13485: 2016 Requirements and Compliance to Latest Updates 2019 covers topics such as:
- EU Notified-Body expectations under ISO 13485: 2016 and the MDR – with the recent major revisions to both
- Smart tips to ensure implementation and maintenance of the changes in your QMS
- Alignment of MDSAP for ISO13485:2016 for readiness to expand your market
- How can a company develop and maintain a dual QMS (EU and USFDA) and prepare for additional Geographies associated with MDSAP?
- Maintaining overall compliance under increasing regulatory expectations
- Discussion of ISO 14971 (Device Risk Management) and IEC 62366-1 (Use Engineering / Human Factors) and where they fit
- Similarities and differences in the FDA and ISO13485:2016, after FDA has taken the path of MDSAP how do you continue to comply to ISO13485:2016?
ISO 13485: 2016 Requirements and Compliance to Latest Updates 2019 is intended for:
- Quality Control Departments
- Quality Assurance Departments
- Research and Development Departments
- Regulatory Affairs Departments
- Engineering Departments
- Manufacturing Departments
- Supplier Management Teams
- Operations Departments
- QA/QC CAPA Admins
- Auditing Management Teams
- Suppliers to medical device industry
- ISO 13485 Implementation Team Members
