BSI’s Overview of ISO 14971:2007 provides information on the impact that ISO 14971 has on the decision making process of a medical device manufacturer who is registered or soon to be registered to ISO 13485. This webinar offers medical device professionals insight into how ISO 14971 can improve business and risk management efforts. An experienced instructor will lead participants through exercises and discussion points, and participants are encouraged to ask specific questions about ISO 14971 and risk management as applicable to their organizations.
Learning objectives
- Understand the clauses of ISO 14971
- Discuss statements of applicability
- Understand how ISO 14971 applies to ISO 13485
- Understand how management is expected to support the implementation of ISO 14971
- Discuss leveraging existing efforts to help meet ISO 14971 requirements
- Identify the variables that will drive the cost and duration of implementation
Who should attend
- Quality decision makers on management system strategy at medical device manufacturing firms
- Management team of medical device manufacturers
- Quality managers
- Auditors of medical device manufacturing firms (internal and external)
- Consultants
- Regulators
Prerequisite
General awareness of ISO 13485 and experience in a medical device manufacturing environment is recommended.
System Requirements
An internet connection with at least Microsoft Internet Explorer 5 or Netscape 5. Also, Corporate Firewalls may prevent the dowload of the MP3 Audio file which can cause the course to hang. Only your IT department can determine if MP3's are being blocked.
