OPIS for Medical Devices
To date, more than 10.000 medical devices are available on the market and the number corresponding to the amount of medical devices approved by the authorities in charge in the last 2 years has been 10 times greater than the one appraised to drugs.
When it comes to medical devices, the complexity and the variety of the possible therapeutic applications require extensive experience in all the aspects of the authorization process.
To use medical devices rationally, health-care professionals must base their choices about which devices to recommend for individual patients on an objective assessment of their safety and clinical efficacy.
The evidence submitted by manufacturers when seeking approval of their high-risk devices must be publicly available, including the technical performance and premarket clinical studies. Giving physicians access to this information supplements the peer-reviewed scientific literature and might be essential for comparing alternative devices within any class. Interested patients should be encouraged to review the evidence for any device that has been recommended for them. The new EU law on medical devices states that the manufacturer is to prepare a summary of the evidence for any implantable or high-risk device.
OPIS has an experienced medical and scientific writing staff with a specific strong expertise in Clinical Evaluation Reports (CER) following the new rules established by the New EU Medical Device Regulation (MDR).
OPIS has the necessary expertise and know-how to take on this challenge and provide excellent service to the Sponsors that are investing in this field in order to bring new products to the market.
Our team of experienced clinical monitors and project managers works according to our certified ISO 9001 quality system under the direction of a Global Trial Leader who is the single point of contact with the Sponsor.
Regulatory and quality experts can review the available technical documentation to propose directions along the specific regulatory pathway to get your medical device registered rapidly and cost-effectively.
- Clinical strategy development & Scientific Advice
- Clinical evaluation report (CER) writing
- Clinical investigation plan (CIP) design and writing
- Clinical investigation report writing
- Investigator brochure & instruction for use writing
- Informed Consent form compliant with global/local regulation
- Site feasibility & Site Selection
- Clinical project management
- Monitoring Activities
- Data management & Statistics
- EDC Web Platform development
- Regulatory and Ethics Committee submissions
- Clinical Trial Agreements (CTAs)
- Grant Management
- Materiovigilance and post-market surveillance
- Quality Consultancy
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