Dates:
To be verified
Duration: 1 Day
Location: 7 Centre Court, Blyry Business and Commercial Park, Athlone.
Accreditation: Certificate of attendance
Full Fee: €395
Course code: CVPM
Programme overview
The new MDR (Medical Device Regulation) 2017/745 has raised the bar on not just the requirements surrounding clinical evidence, but the level of examination now carried out by notified bodies on Clinical Data.
The EU MDR is setting the framework for busy times ahead for medical device practitioners looking to meet the new higher bar requirements set out by the MDR and clinical evidence plays a big role in increased workload. The Frequency of updates to the Clinical Evaluation Report (CER)has changed. Qualifications of report authors and evaluators is now under scrutiny. You now must define Specific and measurable objectives for the CER and establish Scientific validity of data been presented to the notified body. Updates to CERs may also trigger updates to Instructions for Use; make sure they are in alignment. Clinical investigations must be conducted within the constructs of the new legislation and recognized ethical principles.
Who is the course for
- Medical Device practitioners who have to compile CER’s (Clinical Evaluation Reports)
- Regulatory personnel who have to complete Technical Files for CE marked medical devices
- Anyone who has an interest in CERS
Learning outcomes
- Understand what is Clinical Evaluation and what are the Clinical Evaluation Guidance Documents
- Understand Clinical Evaluation Requirements under new MDR
- Understand Methodology employed to carry out CER (Clinical Evaluation Report)
- Understand the Requirements of Literature Search and Screening
- Understand the Fundamentals of good medical writing
- Greater understanding of layout oy CER (Clinical Evaluation Report)
- Compliance to Post Market Clinical Follow up
Course Content
Module 1:
Introduction to Clinical Evaluations
- Overview of medical device regulation in Europe
- Overview of relevant Directives and Guidance
- Impact of the Medical Device Regulation (MDR)
- Impact of MedDev 2.7.1 Rev 4
- Introduction to ISO 14791 – Risk Management for Medical Devices
Module 2:
Clinical Evaluation Process
- Overview 5 key stages
- Finding the clinical data – clinical literature review
- Assessing the clinical data
- Analyse the clinical data
- Conformity with the Essential Requirements
Module 3:
Clinical Evaluation Report (CER)
- Overview of the Clinical Evaluation Report (CER) content
- Who should write the CER?
Module 4:
Clinical Evaluation Throughout the Product Lifecycle
- When to conduct a clinical evaluation
- Stage 1: Device development
- Stage 2: Initial CE-Marking equivalence
- Stage 3: Post market
Module 5
Post Market Clinical Follow-Up
- Overview of relevant Directives and Guidance
- Post Market Surveillance – where does PMCF fit in?
- Why do we need PMCF?
- PMCF study design
- Implementing PMCF
Trainer Profile
TP Lowry has over thirty years in medical device and pharma industries working as Analyst, Engineer, Quality Manager to Operations Director. Consultant for the past sixteen years
MBA , Doctor of Quality Management
