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Clinical Evaluation for Medical Devices
- based on MEDDEV 2.7/1 rev 4 and the requirements within the MDR
During this two-day course you will get a good insight into the key steps of performing a Clinical Evaluation and how to fulfill the requirements. The course is focused on practical aspects of Clinical Evaluations with group discussions, case studies and examples.
This course provides practical guidance on how to perform a Clinical Evaluation, how to write both plan and report, and discussions on how to make it fit your device while meeting the requirements. We will go through the stages of the Clinical Evaluation process (scoping, identifying data, appraise data and analysis) including practical tips on how to do the systematic literature review.
During the course you will also go through how to grade and weigh the validity of clinical data. We will also highlight the major changes in relation to the new Medical Device Regulations (MDR). Post market clinical follow-up (PMCF) is discussed, with rationale for when it is not needed.
At the end of this course, participants should have a better understanding of how to define clinical data and how it is used to support a device’s intended use and claims.
Furthermore, the participant should be able to describe the clinical evaluation process, including the stages under MEDDEV 2.7/1 rev 4 and its role in the product life cycle, including writing the plan and report. In addition, a basic understanding of how to perform a systematic literature review as well as how to collect data for a state-of-the-art (SoTA) overview.
- Scoping and Planning
- How to adapt the evaluation to your device
- Define your PICO- summarize in literature search plan
- Identifying pertinent data
- How to perform a systematic literature review
- Practical tips when performing literature search
- State-of-the-Art discussion
- Appraisal of clinical data
- Useful tools, templates, and tables
- Consider risk of bias, scientific validity, relevance, and weighting
- Analysis of clinical data
- Useful tools, templates, and, tables
- Consider compliance, key requirements
- Post market clinical follow-up and justifications
- MDD, MEDDEV 2.7/1 rev compared to the MDR requirements
- Case studies, with examples of software as a medical device
Who should attend:
The course is suitable for persons working in the field of medical devices with regulatory, quality, risk management, and clinical investigations who needs to write, review, and/or audit clinical evaluation reports.
Need of prior knowledge/experiences:
- You should have basic knowledge of how to perform scientific data base searches
- You should have experience in writing regulatory reports /medical writing
- You should have at least 6-12 months experience of working in the regulated industry (medical device or pharmaceutical industry).
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Intermediate / Advanced
EU, US and
global (ISO 13485)
Date, location and venue:
This course is also offered in-house.
Click here for more info and inquiry form.
09.00-17.00 (Registration 8.30-09.00 day 1)
Register by 28 Oct - Save 1 500 DKK (€ 200)
Until 28 Oct: 13 780 DKK (€ 1 850)
From 29Oct: 15 280 DKK (€ 2 050)
Incl. course material (pdf), lunches and refreshments
Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.
For groups registered and invoiced together for the same course we offer the following quantity discount:
3 persons or more 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
3-5 days prior the course you will receive a download link for the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
Cancellation of registration:
Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 14 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.
Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.