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.
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
|
Time |
Topic |
|
Online Self-Paced |
|
|
Day 1 |
|
|
Day 2 |
|
|
Day 3 |
|
|
Day 4 |
|
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 [email protected]. 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 [email protected] 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
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speaker
Rod Beuzeval
