Key changes to the ISO 13485:2016
Effective Gap Assessment with ISO 13485
Updating your procedures to ensure compliance on an ongoing basis
Observing every individual element that had been enhanced under ISO 13485: 2016
Successfully auditing to the new standard (closing all CAPAs from the audit)
Changes in the control of nonconforming products and CAPA expectations
Training employees with the new procedures to ensure compliance to the new ISO standard?
Smart tips to ensure implementation and maintenance of the changes in your QMS
EU Notified-Body expectations under ISO 13485: 2016 and the MDR – with the recent major revisions to both
How can a company develop and maintain a dual QMS (EU and USFDA) and prepare for additional Geographies associated with MDSAP?
Alignment of MDSAP for ISO13485:2016 for readiness to expand your market
Discussion of ISO 14971 (Device Risk Management) and IEC 62366-1 (Use Engineering / Human Factors) and where they fit
Maintaining overall compliance under increasing regulatory expectations
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 Assurance Departments
Quality Control Departments
Regulatory Affairs Departments
Research and Development Departments
Manufacturing Departments
Engineering Departments
Operations Departments
Supplier Management Teams
Auditing Management Teams
QA/QC CAPA Admins
ISO 13485 Implementation Team Members
Suppliers to medical device industry