Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly.
There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to a great extent, but not completely. This webinar sets forth the requirements for recalls, removals, and market corrections, and provides recommended practices.
Why should you attend: There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. If not, FDA`s sanctions could be so onerous as to result in the company`s inability to ship product.
Areas Covered in the Session: - Regulatory definitions of recalls, removals, and market corrections
- Instances which require recalls, removals, or market corrections
- What to do during recalls, removals, and market corrections
- Recordkeeping requirements for recalls, removals, and market corrections
- ISO 13485-specific requirements
- CMD-specific requirements (Canadian device regulations)
Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since personnel training is a regulatory requirement in the Medical Device field. The employees who will benefit include:
- Regulatory Management
- Quality Assurance Professionals
- Consultants
- Sales/Marketing Management
- Senior and mid-level Management
- Quality System Auditors
