December 17, 2020 - December 17, 2020
Date: 17th of December, 2020
Time: 17:30-19:00 CEST | 8:30-10am PST | 11:30am-1pm EST
Location: Virtual, Live Q & A
While MDR reinforces many of the practices and norms from ISO 14971:2019 (and EN ISO 14971:2012) and aligns well with them, it also emphasizes a few key points, such as the connection between manufacturing controls and risk management. One might also argue that some of the language in the PMS plan and CEP (as well as SSCP) - e.g.
- Annex III – indicators and threshold values for continuous benefit-risk - in PMS plan,
- Annex XIV - a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects; and an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device – in the CEP,
- Risk quantification in SSCP – MDCG 2019-9, pushes us in a more quantitative risk management direction than was the case historically under MDD. This webinar will review these aspects and give some ideas of how one might implement these requirements, with some practical examples and case studies.
- Understand the connections between manufacturing controls and risk management, emphasized in MDR.
- Work through case studies of the connection between clinical data and occurrence of harm to illustrate and help develop the thought process needed to implement this in your organization.
- Discuss the potential need for, and how one might address, some of the “quantitative” risk aspects in the PMS plan, CEP and SSCP.