EU MDR 2017/745 and ISO 14155:2020
Preparing regulatory documentation for a medical device product requires strong scientific, medical, and technical expertise. At AKRN Scientific Consulting, preparing regulatory documentation is our passion. As specialists in clinical regulatory documentation, we provide services that are more than just writing the documentation.
We also work as a training partner for our clients, and our specialists can function as integral parts of our client’s teams and teaching them how to proactively plan, coordinate and write their clinical and scientific documentation to meet aggressive timelines, with a readability that reduces the time for review and approval.
ROADMAP TO CE MARK
We can provide you a comprehensive overview on how to obtain the EU CE Marking of your medical devices that is compliant with European requirements.
Compiling the technical documentation is a critical step in Europe’s CE Marking Process and it is important to be versatile in the requirements of the Medical Devices Directive 93/42/EEC, the Medical Devices Regulation MDR 2017/745, and the ISO20916:2019 equivalent to the ISO 14155 for In-vitro diagnostics Regulation IVDR
TECNICAL DOCUMENTATION
Our training is focused on a step-by-step review of the requirements of technical documentation which includes information about the design, function, composition, use, claims, and clinical evaluation of the medical device.
A technical file is required for all classes of devices (Class I, IIa, IIb, and III) and we discuss the difference between the technical files and which kind of information should be emphasized in each case.
- What are the Essential Requirements / GSPRs
- How to compile your EU Technical File
- How to determine applicable testing requirements and standards for a device
- What is clinical data and the clinical evaluation
- The purpose of risk assessment
- Understanding labeling and instructions for use
- How to set up a state-of-the-art literature research
INTRODUCTION TO ISO14155:2020
This international standard addresses good clinical practices for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes. This course is an introduction to ISO 14155:2020 with a particular focus on the informed consent process, protocol (CIP) development, CRF development, quality control, and compliance and monitoring, investigational device handling, EC/CA submission, safety reporting, and good documentation practices.
KEY CLINICAL AND REGULATORY PLANS AND REPORTS
Clinical and regulatory documentation and are far too important to be left to chance. We offer several courses on how to prepare best-in-class clinical and regulatory documentation.
No program is too small for well-written protocols, study reports, or submission dossiers. The success of clinical development programs, medical device approval, and marketing depend ultimately on the readability and reviewer-friendliness of the documentation.
- How to prepare Clinical Literature Research and Report according to MEDDEV 2.7/1 Rev 4
- How to write a Clinical Evaluation Report (CER) compliant with MDR 2017/745
- How to write a Clinical Investigational Plan (CIP) compliant with ISO14155:2020 and MDR 2017/745
- How to write a Clinical Study Report (CSR) compliant with ISO14155:2020
- How to prepare a Post Market Surveillance (PMS) Plan compliant with MDR 2017/745
- How to write a Post Market Clinical Follow Up (PMCF) Plan
- How to develop an Investigator Brochure (IB)
AKRN offers a comprehensive MedTech training program with best-in-class teachers. We are working on MedTech companies both in Europe and the United States and we would be happy to know how we could help you too!
Special rates for multiple participants apply. Please contact us for a group proposal.
