Clinical evaluation and clinical trials
What are Clinical Affairs? Basically, it is about demonstrating clinical benefit in the practical use of medical devices. Clinical evaluations and clinical trials are the supreme disciplines in the conformity assessment of medical devices - they require distinct medical, technical, and methodological expertise.
PMS, PMCF, CER, PSUR - Clinical Affairs for Medical Devices under MDR
The new Medical Device Regulation (MDR) has tighter requirements for Post-Marketing Surveillance and Clinical Evaluation, and places much clearer emphasis on the collection of clinical data.
Clinical data is used to substantiate statements on the safety and Clinical Performance of products. In addition to the data generated in the pre-marketing phase, clinical data must also be collected and evaluated by the manufacturer as part of Post-Market Clinical Follow-up (PMCF).
The relationships of Clinical evaluation to adjacent processes and required evidence are to be considered more complex than ever before. To further assist your inquiry:
Challenges in Clinical Evaluation, Post-Market Clinical Follow-up (PMCF) & Co. for Medical Devices
Some questions always arise when it comes to Clinical Affairs under the MDR:
- You are worried that your Clinical Evaluation is "outdated"? Your Medical Device is "merely" an accessory...how can you write a Clinical Evaluation?
- Clinical Evaluation, PMS, PMCF...everything revolves around clinical data. What exactly is that anyway? And where do we get it from?
- CER, PSUR, Clinical Development Plan... who is supposed to prepare all of this documentation? And who is authorized to do it?
- What is the best way to “bring it all together” and come to understanding? What is the concept behind all of it? Is there a way to make it possible for companies and manufacturers of all sizes, and not just the big corporations?
Clinical Affairs: qtec as your partner in clinical evaluation
Meanwhile, the demands on the qualification of the author of a Clinical Evaluation are so high that they can hardly be combined in one expert.
Because the discoveries from Risk Management, Post-Market monitoring, and the CAPA system are directly linked to Clinical Evaluation, efficient teamwork is a key point for success.
The collection of Post-Marketing Clinical Data (PMCF data) often requires creativity and the exploration of the manufacturer's options.
- Adequate work on interfaces,
- Well coordinated, and efficient communication
- Well-trained employees in the company, e.g. in collection and analysis of statistical data
Because of this, we are more than happy to more than just write a Clinical Evaluation for you; we are ready both to be persistent and helpful.
Our work is going to positively develop and educate you and your employees by offering self-help and qualifying your employees.
- Areas: Europe, Worldwide / Updates, New regulations and guidances 25/23
- Areas: Europe, Worldwide / Updates, New regulations and guidances 15/23
- In China, Post Market Surveillance (PMS) is an important component of the regulation for medical devices, ensuring the safety and effectiveness of these products.
- Areas: Europe, Worldwide / Updates, New regulations and guidances 05/23