Clinical Affairs
Clinical Affairs:
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.
Clinical Affairs
Performance portfolio
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:
An overview of our products
Many projects, one standard: clinical evaluations at the highest level. The following products - and many more - have been supported by our team, backed by solid evidence and full MDR compliance.
- Wound Care / Dressing Materials
- Bandages & Fixation / Compression & Tapes
- Surgical Instruments / OR Tools
- Diagnostics / Imaging / Microscopy
- Implants / Specialized Devices
- Medical Equipment & Systems
- Consumables & Disposables / Hygiene / Protection
- Infusion / Catheters / Delivery / Collection
- Special / Miscellaneous
- 2-layer compression bandages
- Absorbent wound dressing
- Composite wound dressings
- Compression bandages
- Cooling bandages
- Silicone wound dressing
- Crepe bandages
- Debridement wound dressing
- Film dressing
- Foam plaster
- Foam-based wound dressing
- Gauze dressings
- Hydroactive wound dressing
- Hydrocolloid wound dressing
- Medicated absorbent wound dressings
- Non-adherent wound dressing
- Ointment dressing
- Silicone scar reduction plaster
- Superabsorbent wound dressing
- Strips & wound plasters
- Transparent film dressings
- Wound closure strips
- Wound powder
- Adhesive tape / rolls
- Fixation bandages / rolls
- Fixation (sport) tapes
- Adhesive fixation
- Long-stretch bandages
- Short-stretch bandages
- Tubular bandage
- Padding bandage
- Support / relief bandages
- Basic instrument sets (scissors, forceps, hemostatic clamp, needle holder, gauze)
- Bipolar applicator
- Bipolar forceps
- Hemostatic forceps
- Needle holder
- Scissors
- Rigid laparoscopes
- Shoulder arthroscopy
- Knee arthroscopy
- Hip arthroscopes
- Laryngo-pharyngo retractor
- Confocal microscope
- Operating room microscopes
- Picture Archiving and Communication System (PACS)
- Video telescopes
- Endoscopic video imaging
- Implant-supported bridges and bars
- Temporary prostate implant
- ECMO
- ECMO console
- ECMO sets
- HF (high-frequency) generator
- Extracorporeal shock wave therapy device
- Vessel sealing system
- Disinfectant / Wound disinfectant
- Isolation gowns
- Surgical gowns / Scrub suits
- Surgical cap
- Medical face masks
- Examination gloves
- Catheter
- Coronary guide catheter
- IVR microcatheter
- Devices for motor/musculoskeletal systems
- Flushing pumps
- Suction pump
- Patient transfer sheet
- Gel freezing bag
- Freezing bag
- Wound irrigation solution and gel
- Nasal/oral sea salt spray
- Gene assay
- Polyp trap (IVD)
- Specimen receptacle for dried blood spot collection (IVD)
- Sperm separation system
- Stem cell separation system
- Software
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.
This requires
- 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.
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