Uncovering and Managing Successful Post Market Compliance for Medical Devices 2018 is a conference that covers topics such as:
- Firms MDR reporting and FDA`s handling of MDR reports
- How to comply with complicated Compliant Handling, MDR and Recall requirements
- Risk of regulatory enforcement actions
- Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA
- Relationship and interaction with other quality system elements as they relate to complaints and reportable events
- Creation and maintenance of effective procedures for handling complaints, reportable events and recalls
- Designing Standard Operating Systems for communicating process for firm`s success
- Case examples
- FDA`s New Guidance`s on Risk and how it interacts with Recalls
Uncovering and Managing Successful Post Market Compliance for Medical Devices 2018 brings together attendees from:
- QA/QC
- Regulatory Affairs
- Regulatory Professional
- Project Managers
- Complaint Handling Teams
- Risk Managers
- CAPA Teams
