Why Should You Attend:
In the U. S., the Quality System (QS) Regulation (21 CFR Part 820) governs the manufacturing of medical devices, the device CGMPs. Outside the US, the majority of countries utilize ISO 13485, the international quality management systems standard for medical devices, together with EU’s MDR (Medical Device Regulation). What is the importance, and purpose, and the framework of ISO 13485’s basic requirements for design and manufacture of medical devices, as well as a summary of the key requirements, the 8 sections, terms, and the underlying purpose for the requirements? “Establishing, implementing and maintaining a company QMS under ISO 13485:2016 and a Notified-Body. Major discussion points: Regulatory requirements of the EU, that apply to the methods, facilities and controls used for device design and development, production, installation, documentation, and servicing. Also: the Quality Management System, Management Responsibility, Managing Resources, Planning, Design and Development / Control, Change Control, Purchasing, Production, and Monitoring, Analysis, and Improvement. Unique requirements of the EU device regulations.
Areas Covered in the Webinar:
What are EU Notified-Body expectations under ISO 13485 and the MDR – with the recent major revisions to both?
How can a company develop and maintain a dual QMS.
Basic Systems / SOPs.
Brief discussion of ISO 14971 (Device Risk Management) and IEC 62366-1 (Use Engineering / Human Factors) and where they fit.
Current areas of EU concern.
Maintaining compliance under increasing regulatory expectations.
Similarities and differences in the FDA and EU QMS’.
In the U. S., the Quality System (QS) Regulation (21 CFR Part 820) governs the manufacturing of medical devices, the device CGMPs. Outside the US, the majority of countries utilize ISO 13485, the international quality management systems standard for medical devices, together with EU’s MDR (Medical Device Regulation). What is the importance, and purpose, and the framework of ISO 13485’s basic requirements for design and manufacture of medical devices, as well as a summary of the key requirements, the 8 sections, terms, and the underlying purpose for the requirements? “Establishing, implementing and maintaining a company QMS under ISO 13485:2016 and a Notified-Body. Major discussion points: Regulatory requirements of the EU, that apply to the methods, facilities and controls used for device design and development, production, installation, documentation, and servicing. Also: the Quality Management System, Management Responsibility, Managing Resources, Planning, Design and Development / Control, Change Control, Purchasing, Production, and Monitoring, Analysis, and Improvement. Unique requirements of the EU device regulations.
Areas Covered in the Webinar:
What are EU Notified-Body expectations under ISO 13485 and the MDR – with the recent major revisions to both?
How can a company develop and maintain a dual QMS.
Basic Systems / SOPs.
Brief discussion of ISO 14971 (Device Risk Management) and IEC 62366-1 (Use Engineering / Human Factors) and where they fit.
Current areas of EU concern.
Maintaining compliance under increasing regulatory expectations.
Similarities and differences in the FDA and EU QMS’.
