Module 16 2022

05/09/2022

Organisational Structure of a Medical Device NB

Varies between NB but requires a wide range of expertise and resource needed to demonstrate competency & capability • Sales and Contract Support • Technical Experts / Product Reviewers • Scheme Managers / Project Leaders • QMS Auditors • Clinical Team • Certificate Decision Makers • Regulatory & Compliance • Training

The Organisation for Professionals in Regulatory Affairs

7

Client Application & Contractual Agreement

• Manufacturer makes application and needs to provide all relevant information to allow Sales Quotation and Contract review and issuance

• Scope of QMS • Product Scope • Identify Key Personnel • Declares readiness for assessment

Note: NB Contracts usually include the requirement to inform the NB of all Vigilance reports

The Organisation for Professionals in Regulatory Affairs

8