Advanced Regulatory Affairs for Medical Devices Course (London, United Kingdom - October 8-9, 2020) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Advanced Regulatory Affairs for Medical Devices" conference has been added to ResearchAndMarkets.com's offering.

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

The regulatory environment for medical devices is in a transitional period. With the increased focus on patient safety, the MDR has introduced many changes to the requirements and processes involved.

Designed for professionals with a working knowledge of medical device regulatory affairs, this course will provide essential guidance on how to successfully transfer products from the current regulatory system under the Medical Device Directive (MDD) to the new MDR. Regulatory strategy and life cycle management will be a key focus of the programme with comprehensive sessions

on regulatory pathways, technical documentation, clinical evaluations and investigations. There will also be a review of the requirements for the vigilance system, post-market surveillance (PMS) and post-market clinical follow-up (PMCF) studies.

Delegates will cement the knowledge gained through case studies and practical workshops and there will be ample opportunity to discuss the complexities involved with two medical device experts, both of whom have huge knowledge and experience in this field.

Agenda:

Programme day one

• Introduction and pre-market requirements
  

The impact of the MDR on your role and responsibility

• Why a change in regulation?
• Structure of the new Regulation and flow of compliance
• Key analysis of the changes
• Changes to roles and responsibilities of key stakeholders
• Competent authorities and Notified Bodies
• Economic operators - role and responsibilities
• Person responsible for regulatory compliance

Borderlines and classification

• Borderline determination
• Software qualification and classification
• Understanding the classification process
• Investigating the classification rules (emphasis on the new rules)
  

Classification workshop: Practical session in applying the new rules

Ensuring compliance

• General safety and performance requirements
• Changes from old essential requirements
• Additional quality management system requirements from 26 May 2020
• Technical documentation requirements
• Gap analysis of MDR requirements compared with MDD

Requirements for clinical evaluations and investigations

• Requirements, standards and guidance
• Understanding the importance of clinical evaluation
• Key requirements of clinical investigations

Programme day two

• Market entry and post-market requirements
  

The new market surveillance tools

• The European database (EUDAMED)
• Unique device identification (UDI)
• Supply chain surveillance and traceability

Requirements for PMS

• Understanding PMS requirements
• Implementing effective PMS

The new vigilance system

• Management of adverse incidents
• Definitions: what is reportable, the reporting process and investigation
• Corrective action
• Periodic safety update reports - how to manage this requirement

Vigilance workshop: Report or not to report?

PMCF studies

• Requirements for PMCF
• Types of PMCF

The future evolution of the European regulatory system

• Impact of Brexit
• How to meet UK requirements for your medical device
• The challenge of future technology

Speakers:

Janette Benaddi

Director of Clinical & Consulting Europe

NAMSA

Theresa Jeary

Technical Manager for Medical Devices

Lloyds Register Quality Assurance (LRQA)

For more information about this conference visit https://www.researchandmarkets.com/r/utve0g