The “Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course” conference has been added to ResearchAndMarkets.com’s offering.
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 produce 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
- Learn how to appraise data
- Know how to assemble clinical evidence acceptable for review by regulatory authorities or Notified Bodies
Who Should Attend:
- Medical writers
- Clinical staff
- Those who conduct clinical evaluations/investigations/post-market follow-up studies
- Those moving from pharmaceuticals to medical devices
Personnel involved in:
- Gathering clinical evidence and conducting clinical evaluations
- Regulatory affairs
What is a Clinical Evaluation?
- Explanation of the terminology used in clinical evaluations
- Overview of a Clinical Evaluation
- 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)
Mary-Ann Preston is the EMEA manager for medical writing services at NAMSA, a medical research organization providing full-service support throughout the product development process for medical devices, diagnostics, and combination products.
Mary-Ann is responsible for a team of medical writers who prepare clinical evaluation reports (CER), performance evaluation reports (PER), and other documents in accordance with regulatory requirements (e.g. Medical Device Regulation and In vitro Diagnostic Regulation), various guidance (e.g. MEDDEV 2.7/1 revision 4 and medical device coordination group documents) as well as other applicable documents and standards.
She has extensive experience in the critical assessment and interpretation of technical, scientific, and clinical data for CERs, PERs, literature reviews, scientific reports, and regulatory submissions. Utilizing her strong background within the medical devices industry, Mary-Ann has provided regulatory consultation, remediation, and hands-on assistance to clients on all aspects of PERs and CERs.
As well as clinical expertise, Mary-Ann has over 20 years of R&D experience in medical devices. Her background includes the design, development, and management of pre-clinical research for medical devices from scoping, and proof of concept stage through to pivotal development, biocompatibility testing, and in vivo safety and performance studies for regulatory submissions. She has developed medical device expertise in the therapeutic areas of dermal wound healing, sports medicine, and orthopaedics.
Mary-Ann is a biochemist and cell biologist by training, with a Ph.D. in dermal wound healing and scarring.
Before joining NAMSA, she held various senior roles at another consultancy and a leading manufacturing company, Smith & Nephew.
For more information about this conference visit https://www.researchandmarkets.com/r/bgw3kt