RAPS Workshop: Clinical Evaluation for Medical Devices (April 2026)

Is clinical evaluation causing challenges for your organisation? Have you received feedback from your notified body that you're unsure how to address?

In this course, you will establish a strong foundation in the principles of clinical evaluation gaining the necessary knowledge, skills, and expertise to create compliant clinical documentation. Whether you are new to medical devices or looking to strengthen your current understanding, this course will give you an excellent grounding in the EU requirements for clinical evaluation.

Registration Fees & Deadlines

Learning Objectives

• Understand what equivalence is and whether you need it
• Define what state of the art is and how it is used
• Identify safety and performance parameters and how they are used
• Understand how processes such as PMS and Risk Management link with clinical evaluation
• Apply systematic methods to gather and appraise data
• Construct your Clinical Evaluation Report to ensure compliance
• Determine the level of sufficient evidence required for your CER
• Locate and utilise available guidance
• Be aware of the clinical evaluation requirements and how the type and class of a device has an impact

Who Should Attend?

This course is suitable for anybody that requires an understanding of clinical evaluation. A basic understanding would be advantageous.

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Agenda

Speakers

Rod Beuzeval, RAC
Principle Trainer, Leap Compliance

Rod brings a wealth of worldwide regulatory knowledge and quality assurance experience to companies wanting to design, manufacture, and market compliant medical devices. He has worked in the medical device and pharmaceutical industry for over 22 years, including time spent in some of the largest medical device and pharmaceutical manufacturers. Rod’s experience has involved providing regulatory strategy from product development to worldwide market registration, creation of technical documentation, implementation of full 13485 compliant QMS systems, standards compliance, clinical evaluations, risk management files, project management and remediation activities. Rod has also spent time working for a notified body, conducting audits against ISO 9001, ISO 13485, 21CFR820, MDSAP, cGMP and GDP. Rod’s device experience covers Class I, II and III devices, including software as a medical device, drug delivery devices, IVDs, and active implantable medical devices. More recently, Rod has helped clients update their clinical evaluation processes to the requirements of the MDR, updating risk management systems to the latest standard and delivering training on MDR, IVDR, clinical evaluation, risk management, MDSAP and QMS systems.

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions