Location

Productivity and Quality Institute - Alexandria

Objectives

• Understand what a Quality Management System isUnderstand how a Quality Management System works practically in a Medical Device companyUnderstand the elements of a Quality Management System and how they work together

Outcomes

Know how to design an FDA/ISO compliant Quality Management SystemKnow how to development a complete set of Quality Management System proceduresKnow how to implement an appropriate Quality Management System for a Medical Device company

Course Contents

• Introduction to QMS• Introduction to ISO 13485 and Medical Device Regulation Conformity Assessment• Introduction to the EU Medical Devices Regulationso The pitfalls and opportunitieso The interested parties• Compare the requirements of ISO 13485 and ISO 9001 and update on the ISO 9001: 2015 revisionso The advantages and disadvantages of continuing with certification to both Interpretation of ISO 13485 and what it means in practice for the QMS requirements in the MDR Including timescales.• How to achieve ISO 13485 certification?• Understanding the new requirements and structure• Performing the gap analysis• Managing your transition to the 2016 version of the Standard• Examples of ISO 13485 non-complianceso How they are gradedo How to fix them• Understanding the roles and responsibilities of top management in ISO 13485• Compare and contrast the requirements between ISO 13485 and FDA’s Quality System Regulation• Unannounced Auditso What to expecto How to prepare•