The presentation will review the complete requirements for Risk Analysis and give an example of how a company can easily create a Risk Analysis in full compliance with the standard. The information will assist in meeting various national and global regulatory requirements for medical devices.
Medical Device companies are creating Risk Analysis as required by ISO 14971, yet the analyses created do not meet the requirements of the standard. Many companies are using Failure Modes and Effects Analysis as their complete Risk Analysis, and are not in compliance with the standard. The presentation will review the complete requirements for Risk Analysis and give an example of how a company can easily create a Risk Analysis in full compliance with the standard.
Design personnel using risk management during development of new medical devices.
Quality Manager responsible for integrating risk management into quality systems.
Regulatory and compliance personnel who develop premarket filings and technical files for medical devices.
Personnel responsible for verification and validation activities.
Quality system auditors.
Medical Device companies are creating Risk Analysis as required by ISO 14971, yet the analyses created do not meet the requirements of the standard. Many companies are using Failure Modes and Effects Analysis as their complete Risk Analysis, and are not in compliance with the standard. The presentation will review the complete requirements for Risk Analysis and give an example of how a company can easily create a Risk Analysis in full compliance with the standard.
Areas Covered in the seminar:
- Requirements for Risk Analysis under ISO 14971
- Creation of documentation meeting the requirements
- Documents that meet the requirements and provide value to the company
Who Will Benefit:
This webinar will update personnel at medical device companies on the new standard and point them to the additional information available in the newly revised document. The information will assist in meeting various national and global regulatory requirements for medical devices.Design personnel using risk management during development of new medical devices.
Quality Manager responsible for integrating risk management into quality systems.
Regulatory and compliance personnel who develop premarket filings and technical files for medical devices.
Personnel responsible for verification and validation activities.
Quality system auditors.
Course Provider
Edwin L Bills,
