Medical Device Regulation (MDR) Implementation Training

The aim of this course is to provide Learners with knowledge and understanding of the additional requirements within the Medical Device Regulation (MDR), as well as of the current directives (MDD 93/42/EE) and ISO 13485:2016, including the terminology used and the certification requirements.

My Offerings

Description

The aim of this course is to provide Learners with knowledge and understanding of the additional requirements within the Medical Device Regulation (MDR), as well as of the current directives (MDD 93/42/EE) and ISO 13485:2016, including the terminology used and the certification requirements.

Course Content:

SESSION 1: SCOPE, DEFINITIONS AND CLASSIFICATIONS

Scope of the MDR

Relevant MDR definitions

Delegated and implementing acts

Common specifications

Scope of classification under the MDR


SESSION 2: CONFORMITY ASSESSMENT PROCEDURES

Conformity assessment procedures

Certification process requirements within MDR

Additional requirements under MDR Annex XII

EU declaration of conformity

Criteria for notified bodies and how this is achieved


SESSION 3: QMS REQUIREMENTS

QMS and regulations

QMS application

QMS audit

QMS surveillance


SESSION 4: GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

GSPR matrix

GS & PRs vs MDD ERs


SESSION 5: TECHNICAL DOCUMENTATION REQUIREMENTS

Technical documentation requirements

Conformity assessment


SESSION 6: CLINICAL EVIDENCE REQUIREMENTS 

Clinical evaluation 

Clinical investigations

Post-market clinical follow-up

Clinical evaluation plan


SESSION 7: POST-MARKET SURVEILLANCE AND VIGILANCE

Post-market surveillance life cycle

Guidance documents

Post-market surveillance plan

PMCF

PMCF study


SESSION 8: RISK MANAGEMENT REQUIREMENTS

General safety and performance requirements

Usability review

Design life cycle


SESSION 9: IDENTIFICATION AND TRACEABILITY

Traceability of devices

Identification in supply chain

Unique device identifiers and the UDI system


SESSION 10: SUPPLY CHAIN REQUIREMENTS 

Economic operators and their general obligations

Other economic operators

Systems and procedure packs


SESSION 11: TRANSITION AND NEXT STEPS

Transition requirements

Transition plan


SESSION 12: IBUSINESS IMPACT, TIMELINE AND PORTFOLIO PLANNING

Step 1: Understand the detail of the MDR.

Step 2: Project Planning



Objectives

Upon completion of this course, Learners will be able to:

* Identify the links between ISO 13485:2016 (QMS) and MDR EU/2017/745;

* Explain how terminology has changed and where gaps require additional work for clients to meet the new requirements;

* Define new requirements for proactive post-market surveillance;

* Outline the stages of the transition from MDD to MDR so that clients can create individual transition plans; 

* Define the key deliverables for all economic operators.


Learners will need to demonstrate acceptable performance in these areas in order to complete the course successfully. Learners who complete the course successfully will be issued a "Certificate of Completion".


Audience

This course is designed for those with a good understanding of Current Medical Directives, the ISO 13485:2016 requirements, terminology used, and requirements to achieve certification. 


Learners attending the virtual training live online will need hardware, internet connection and audio connection for the full duration of the course.


View Details

45210352

2 Day

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