This Post-market Surveillance (PMS) webinar will discuss in detail the clinical evaluation and risk management requirements as described in MedDev 2.7/1 Rev. 4, EN ISO 14971:2012 and EN ISO 14971:2012 standards and how they are related. It will also explain some of the recent changes in EU medical device regulations.
MedDev 2.7/1 Rev. 4 describes the initial Clinical Evaluation, but also provides considerations on the update content and frequency.
EN ISO 14971:2012 requires collection and analysis of post-production information to verify continued risk acceptability.
EN ISO 14971:2012describe the Post-market Clinical Follow-up process used to gain information about specific situations such as residual risk.
These three tightly linked processes provide the basis to show the device continues to be safe and effective. With the publication of the EU-MDR, these concepts remain the same, but some of the details will change. The presentation explains some of these changes.
Why Should You Attend:
Post-market Surveillance (PMS) is a crucial element of putting a device on the market in the EU. The PMS process feeds information to other processes to ensure they are current. Two of the most important are the Clinical Evaluation update and the Risk Management update. This presentation explains the updates and shows how they are connected. In addition, the Post-market Clinical Follow-up provides additional information in specific cases.MedDev 2.7/1 Rev. 4 describes the initial Clinical Evaluation, but also provides considerations on the update content and frequency.
EN ISO 14971:2012 requires collection and analysis of post-production information to verify continued risk acceptability.
EN ISO 14971:2012describe the Post-market Clinical Follow-up process used to gain information about specific situations such as residual risk.
These three tightly linked processes provide the basis to show the device continues to be safe and effective. With the publication of the EU-MDR, these concepts remain the same, but some of the details will change. The presentation explains some of these changes.
Areas Covered in the Webinar:
- Identify the source of the requirements in the MDD
- Explain the connection between these activities before and after the initial CE Mark
- Develop a framework for Post-market Surveillance (PMS)
- Show how PMS feeds the three crucial elements
- Describe how these elements supplement each other
- Identify some of the changes from the EU-MDR
- Bonus Material
- Participants receive a checklist to help ensure correct implementation of the processes and procedures.
Who Will Benefit:
- Risk Managers
- Clinical Affairs Professionals
- Product Surveillance Professionals
- Regulatory Affairs Professionals
- Data Analysts
Course Provider
Daniel O Leary,
