IVDR in a nutshell

– how to prepare your Technical Documentation and Quality Management System for a CE-certification and Notified Body review

When preparing for the transition from IVDD into IVDR there are several activities to manage, like updating or creating Technical Documentation and adapting the Quality Management System, which in addition, need to be supported by robust processes for Risk Management and Post-Market Surveillance.

While planning for this you may struggle with questions like; How do I set the scope and objectives for the Performance Evaluation? How do I perform risk analysis, and estimate probability & severity? How do I evidence fulfilment of the ‘General Safety and Performance Requirements? What is the responsibility of the PRRC? What will the NB need look for when auditing our Quality Management System? How to deal with Class A or legacy devices? This training will give you the answers!

Course description

After this 2-day training you will be better equipped to tackle the questions above.  We’ll walk you through the key IVDR requirements on your Technical Documentation and provide you with tools to perform a gap analysis of and update of your quality management system, to ensure compliance with the IVDR. The relationship between IVDR, ISO13485:2016 and other standards such as ISO14971 as well as role & responsibilities of the PRRC will be clarified.

Course outline

  • Understand the impact of IVDR for all aspects of your quality management system
  • Responsibilities of the PRRC – Person Responsible for Regulatory Compliance
  • How to utilize ISO13485:2016 to ensure compliance to the regulation.
  • How to build and structure the Technical Documentation (Technical File)
  • Performance evaluation and the importance of the intended purpose
  • Risk Management– how to define hazards, hazardous situation and harm.
  • Post-Market Surveillance, Post-Market Performance Follow-up, and it’s relation to Performance Evaluation and Risk Management

Learning objectives

Completion of this course will give you the knowledge needed to:

  • Update your technical documentation, to demonstrate compliance to IVDR (or “to GSPR” ??)
  • Assess and update your quality management system
  • Implement and use ISO 14971:2019, both in the Technical Documentation and the QMS
  • Use ISO13485:2016 to manage key regulatory requirements and apply a risk-based approach.

Who should attend

Quality Managers, the PRRC (Person Responsible for Regulatory Compliance), the Management Representative, of an IVD Manufacturer.  Quality Specialists/ Engineers, RA Managers/Specialists, Persons involved in Design & Development,  writing or maintaining Technical Documentation, such as: Design and development engineers,  Quality representatives in design and development projects, or the Head of R&D.

Prerequisites

  • You should have basic knowledge of medical device quality systems.
  • You should have at least 2 years of experience from the medical device industry.

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Date & Time
April 25, 2023
- April 26, 2023
09:00.00-17.00 CET
IndustryIVD, Medical Device
LanguageEnglish
LevelIntermediate
LocationCopenhagen, Denmark
RegionEU
VenueDGI Byen

 1 750

No. persons
Discount:
3 persons or more 15% if registered and invoiced together for the same course.

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Your Instructor(s)

Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.

Åse Ek

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