ISO 9000 & AUDITS WORLD CONFERENCE
Integrating Regulatory Affairs Into the Quality Management System
Presenter: Christine Park, Consultant, Christine Park & Associates, Villa Rica, GA, USA
Keywords: Medical Device File, Document Control, Integration, Regulatory Affairs, Quality Management Systems
As regulations around the world continue to change, there are more and more requirements for documentation. Each standard and or country regulation identifies documentation requirements as appropriate for the business/industry and/or product.. Many of these new Quality System documentation requirements can be met with documents created to support regulatory submissions such as 510k. With the changes is ISO 13485:2016 and the introduction of the MDSAP (Medical Device Single Audit Program) and MDR (European Medical Device Regulations) there is an expectation that key Regulatory activities and documents are now included in the QMS. Additionally, adherence to regulation is now expected to be included in the internal audit processes. This workshop provides explanation to these new requirements and provided guidance for implementation and adherence to the new requirements with minimal complexity. We will work through the following key elements:
• Key roles and responsibilities – Management Representative, Authorized Representative, Person Responsible for Regulatory Compliance
• Product classification – differs from country to country
• Technical Documentation – regulatory documents and quality documents – how to keep it simple!
• Defining and documenting safety requirements
• Regulatory reporting time frames The information presented in this program is based on ISO 13485, Medical Device Regulations for US (21 cfr 820), Europe MDR and IVDR), Canada, Japan, Australia and Brazil. This interactive workshop provides the participant with the opportunity to begin developing plans and tools to address these changes and organize information most effectively. to ensure compliance with the new regulatory and quality system requirements.