Public Training: MDR PMS/PMCF

September 19, 2019

Date: 19th of September 2019

Location: Germany, Munich area

Language: English

Costs: Regular € 875.-

Introduction

Post Market Surveillance (PMS) and its subset of Post Market Clinical Follow-up (PMCF) increasingly become part of the regulatory lifecycle thinking of modern medical device regulations. Moving away from the historic one-time review on compliance prior to market access, PMS needs to be set up as a system that provides continuous feedback about a device on the market in order to maintain a high standard of product quality.

Post-market surveillance requirements are in direct relation to risks associated with the device based on its intended use, such as the product or technology being new to the manufacturer and the extent of the available scientific knowledge and market experience with similar products.  Actual product-specific plans for gathering post-production data about your product or product family need to be set up for the lifetime of the device.

Regulatory bodies across the globe are imposing increasingly demanding and prescriptive requirements for post-market surveillance. In particular, regulatory bodies are establishing specific requirements for more proactive post market surveillance mechanisms, rather than relying simply on reactive systems, such as complaints monitoring.

Note: this training can also be provided in-house for other organizations in the supply chain involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing or provision of associated activities. The contents will be adapted to the specific role(s) of that organization.

Why should you attend this course?

This training focusses on practical guidance to deliver the life-cycle concepts in the EU-MDR on PMS and PMCF. It clarifies why PMS plans and PMCF plans are part of annex II technical documentation that needs to be ready before the market introduction of new products. It will clarify the current interpretation on the differences between active and reactive activities of PMS, and it will provide insight into how to implement the risk-based approach.

The training will give you guidance on how to determine what post-market clinical follow-up (PMCF) data is required and how this should be collected when needed. Furthermore, the requirements for Periodic Safety Update Reports and for Summary of Safety and Clinical Performance will be highlighted. The day will be filled with discussions and case studies.

Learning objectives:

  •  Learn to look at PMS in a practical way, integrating it into daily operations
  •  Learn the difference between active and reactive PMS/PMCF, and when to use what
  •  Understand the full impact of the new EU-MDR on PMS and PMCF principals in continued market approval
  •  Know how to apply PSUR and SSCP
  •  Understand how to build and use checklists, tools, and templates

Program overview:

PMS and PMCF in global setting

PMS and PMCF in EU - Medical Device Regulation

Regulatory Life cycle concepts, embedding PMS and PMCF in QMS

PSUR & SSCP requirements

Case studies

Questions & Answers

Evaluation of the Course and Closing


Who should attend this course?

RA manager, RA director, QA manager, QA director, Clinical Director, Marketing Manager, Sales Manager, international registration department.

Trainer:

Wiebe Postma
Stephanie Valk
Post date: May 10, 2019
Tags
Subscribe to the Qserve Newsletter and follow us on LinkedIn
Want more information? Get in touch with us
Information request