This two-day introductory course will cover all aspects of clinical evaluation in line with the European Medical Device Regulation (MDR) and applicable guidance documents. The programme will provide you with the tools and skills you will need to produce a high-quality clinical evaluation report (CER) for all your medical devices. You will understand the detail of what clinical data is needed, how to collect it, analyse it and receive direction on producing a CER that is acceptable to the regulatory authorities and Notified Bodies. You will learn how the process fits into the development of a medical device and also the post-market aspects of clinical evidence.
The programme includes case studies and template documents which you will be able to utilise to produce your own clinical data evidence documentation.
Benefits of attending
- Gain a detailed overview of the clinical evaluation process
- Understand the concepts involved in conducting a clinical evaluation
- Learn how to utilise information gathered during a clinical evaluation
- Take away skills in conducting systematic literature searches
- Understand where clinical evaluation fits into the development and marketing of medical devices
- Explore how to appraise data
- Know how to assemble clinical evidence acceptable for review by regulatory authorities or Notified Bodies
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
What is a clinical evaluation?
- Explanation of the terminology used in clinical evalutions
- Overview of a clinical evalution
- The importance of clinical evidence in medical device development
Why and when is it necessary to conduct a clinical evaluation?
- Where does clinical evaluation sit within the medical device process?
- Why is clinical evidence important?
- Who are the stakeholders in the process?
Who and what is involved in the clinical evaluation process?
- Overview of each step
- Use of equivalent products
Workshop: bringing it together
- An interactive exercise on what has been learnt so far
What regulations govern clinical evaluations and what guidance documents should clinical evaluations be conducted to?
- An in-depth review of the available regulatory and guidance documents which can be utilised during the process and how to interpret these
Documentation necessary for conducting a clinical evaluation
- The clinical evaluation plan
The literature review process
- Selecting databases and conducting searches
- How to source data and review it
- How to clarify the question on which you need to find literature, including devising the most comprehensive literature search strategy and selecting key words
The Clinical Evaluation Report (CER)
- What is it and what is included?
- Who should write it?
- How to write it
What is state of the art and how to conduct a risk benefit assessment of the data?
- Performance and safety analysis
- State-of-the-art analysis
- Risk-benefit analysis
Impact of the Medical Device Regulations (MDR)
Speakers
Ms Janette Benaddi,
Director of Clinical & Consulting Europe ,
NAMSAJanette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she ahs also provided training to Notified bodies in this subject.
Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.
Who Should Attend
- CROs
- Medical writers
- Clinical staff
- Those who conduct clinical evaluations/investigations/post-market follow-up studies
- Those moving from pharmaceuticals to medical devices
And personnel involved in:
- Gathering clinical evidence and conducting clinical evaluations
- R&D
- Regulatory affairs
