$945 – $1,050

Post Market Surveillance & Vigilance: New Requirements under the EUMDR/IVDR

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$945 – $1,050

Event Information

Location

Location

Online event

Refund policy

Refund policy

Refunds up to 7 days before event

Eventbrite's fee is nonrefundable.

Event description
Post Market Surveillance & Vigilance: New Requirements under the EUMDR/IVDR; 1- Day Training; March 1, 2022

About this event

About the Training

Both Regulation (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) include new and more detailed Post-market surveillance and vigilance requirements.

The transitional provisions described in both Regulations (MDR Article 120, IVDR Article 110), require a manufacturer to implement the Post-market surveillance, market surveillance, vigilance requirements during the transitional period in order to keep placing its Device on the market with a Medical Device Directive certificate after the date of the Regulations application. For the Regulation (EU) 2017/745, it is starting May 27, 2021; for the Regulation (EU) 2017/746, May 27, 2022.

This course has been designed to allow manufacturers to easily identify the key requirements and prepare for their timely implementation.

REQUIRED LEVEL

Basic knowledge of the post-market requirements under the Directives 93/42/EEC, 90/385/EEC and 98/79/EC

Who Should Attend

  • Medical Device Manufacturers: Regulatory Affairs Managers, Quality Managers, Person in Charge of Regulatory Compliance
  • Internal and External Auditors
  • Importers
  • Distributors

Learning Objectives

  • Identify regulatory requirements with regards to Post Market Surveillance and Vigilance
  • Implement new Post-Market Surveillance and Vigilance requirements under Regulations (UE) 2017/745 and (UE) 2017/746
  • Identify tools and forms to be used, methods to implement

Educational Resources

  • Presentations
  • Practical working sessions
  • Course evaluation

Check out the Program:

Day 1

  • Post Market Surveillance and Vigilance requirements
  • Analysis of new requirements
  • EUDAMED Vigilance module
  • Transitional provisions – Notified Body’s expectations
  • Implementation: PMS plan, PSUR, PMCF… (tools, forms, methods)
  • Role of the Notified Body – new activities

About the Trainer

Florianne Torset-Bonfillou

Compliance Director; Lead Auditor & Product Reviewer

Florianne is the Director of the Compliance Department at GMED North America. She has a background in Biology, Chemistry and Quality Management. After working in the Pharma/Device industry, Florianne first joint GMED as an Assessor. She is a Lead Auditor and a Product Reviewer with focus on high risk devices, mainly in the cardio and neurovascular field.

Florianne provides Regulatory support to the local team and is currently focusing on the transition to the European Regulation EU 2017/745 and EU 2017/746.

She is also a trainer on the European Regulation, Quality Management, Risk Management, and other regulatory and quality topics.

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Location

Online event

Refund policy

Refunds up to 7 days before event

Eventbrite's fee is nonrefundable.

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Organizer GMED North America, Inc.

Organizer of Post Market Surveillance & Vigilance: New Requirements under the EUMDR/IVDR

 GMED North America. is the subsidiary of GMED, leading Certification Organization & distinguished Notified Body (CE0459).

GMED is a leading Certification Organization and a distinguished Notified Body (CE0459) whose scope covers all of the existing European Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC).

 

GMED is also an Auditing Organization Recognized by the MDSAP Regulatory Authority Council and has been performing MDSAP audits since April 2015. GMED is accredited under the NF EN IEC/ISO 17021-1:2015 standard by COFRAC (Certificate № 4-0608), the French Accreditation Committee, to carry out Quality Management System Certification activities according to ISO 9001:2015 and ISO 13485:2016. 

 

Established in 1994, GMED is fully owned by LNE (e.1901), a State owned Industrial and Commercial Establishment (EPIC), and operates since August 1st, 2018 as a simplified joint stock company (SAS) within the LNE group. 

 

GMED’s success and high level of performance rely first and foremost on a strong and dedicated team of individuals trained at the highest level of the current evaluation and auditing methods to provide the best certification services: Certification Project Managers, Subject Matters Specialists (MDAO or Medical Device Animal Origin, Medicinal Substance, Active Implantable Medical Devices, Microbiologists), Technical Documentation Evaluators and Design Dossier Assessors, Clinical Reviewers & Experts (Ex: Sterilization Methods and Validation) and Auditors for CE marking and QMS activities. 

 

With offices in Europe and a dedicated US Operation created in 2005 - GMED North America (MD), GMED offers the convenience and efficiency of local teams of experimented specialists to accompany your certification process which will allow you to market in your target markets.

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