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Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free. *This offer cannot be combined with any other promotional offer(s).

New! 

CER (Clinical Evaluation Report) Training for EU MDR Compliance

Can't travel? This class is also available virtually.

The days of 10-page clinical evaluation reports are long gone. Today, Notified Bodies expect to see robust clinical data as a key component of your CE Marking technical documentation…even for low-risk devices. The May 2020 implementation of the EU Medical Device Regulation is sure to further elevate expectations.

Will you be ready?

This 3-day training class will walk you through all aspects of assembling a CER from the ground up as well as improving your existing clinical evaluation to meet new requirements. Using workshops and real-life examples, your instructor will address all facets of clinical data, clinical evidence, and clinical investigations, explaining the requirements for each and detailing all five stages of the clinical evaluation process. You’ll come away with a clear understanding of what is required to ensure that your CER withstands Notified Body scrutiny – and what you need to do to get there.

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.800.472.6477  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
VIRTUAL DELIVERY (PM) 04/27/2020 5 $3495.00 Call to Register CONTACT US
VIRTUAL DELIVERY (PM) 05/11/2020 5 $3495.00 Add to Cart CONTACT US
Austin, TX 06/09/2020 3 $3495.00 Add to Cart CONTACT US
San Diego, CA 06/23/2020 3 $3495.00 Add to Cart CONTACT US
Edison, NJ 07/08/2020 3 $3495.00 Add to Cart CONTACT US
Orlando, FL 09/15/2020 3 $3495.00 Add to Cart CONTACT US
Raleigh, NC 09/29/2020 3 $3495.00 Add to Cart CONTACT US
Boston, MA 10/27/2020 3 $3495.00 Add to Cart CONTACT US

What You Will Learn

  • Clinical evaluation report components related to EU MDR and MEDDEV 2.7/1 rev. 4
  • Relationship of CER to MDR 2017/745, MEDDEV 2.7/1 rev. 4, EN ISO 13485:2016, and EN ISO 14971:2012 
  • Relationship of clinical evidence to clinical data and clinical evaluation, with examples
  • Five stages of clinical evaluation under MEDDEV 2.7/1 rev. 4 and their role in the product life cycle
  • How clinical data is employed to support device purpose and use
  • Clinical investigation requirements under EU MDR, and rationale for when it is not needed
  • Creating a clinical evaluation plan in compliance with EU MDR and MEDDEV 2.7/1 rev. 4
  • Data collection processes and types, including the use of nonclinical data
  • “State of the art” with linkage to benefit-risk analysis
  • Data analysis using clinical literature as well as safety and performance data
  • Creating a PMCF plan for the CER and integrating postmarket surveillance and benefit-risk analysis

Who Should Attend

This class builds on our foundational EU MDR class and is appropriate for anyone working in regulatory, quality, risk management, or clinical roles with responsibility for creating, reviewing, or auditing CERs. Participants are expected to have some basic knowledge of clinical evaluation reports, risk management, and medical device regulation in Europe. 

Number of Days: 3
CEUs: 2.5

Virtual Session Details

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

Training Schedule

This training is delivered as five 3.5 hours sessions.  Each session is a combination of subject matter expert and group discussions, interactive whiteboards, polls, and chat rooms that help students with small group exercises, making this an engaging, interactive learning experience.

A typical public seminar schedule for this class would run:

  • Monday 1:30 PM – 5:00 PM
  • Tuesday 1:30 PM – 5:00 PM
  • Wednesday 1:30 PM – 5:00 PM
  • Thursday 1:30 PM – 5:00 PM
  • Friday 1:30 PM – 5:00 PM

Public seminars are run on the eastern time zone to allow for attendance by west coast attendees. Additional sessions may be offered in other time zones.

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • A computer with reliable, high-speed Internet connection. Broadband is preferable to WiFi.
  • Latest version of browser Firefox, Chrome, Microsoft Edge or Safari.
  • A USB-connected or built-in web cam.
  • A headset with microphone (USB connection recommended).
  • If possible, two monitors; one for the virtual classroom and the other for viewing training materials.
  • A comfortable workstation and a quiet environment.
  • To close your email browsers and refrain from using your phone during the training.
  • Tablets and mobile devices may lack some essential functionalities and are not recommended.

See course dates to find / register for a virtual session of this course.

On-Site Training Close

The dates you choose. The location you want.
The results you need!

Bring any of our classes to your location - Oriel STAT A MATRIX on-site training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.800.472.6477 or Contact Us.

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