Classroom 2 Day
45210352
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.
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.
Classroom 2 Day
45210352