Confirming your Compliance to ISO 13485:2016 Requirements 2019

Topics

• 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?

Who should Attend

• 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