Medical Devices

To date more than 10.000 medical devices are available on the market, and the number of medical devices approved by the authorities in charge in the last 2 years has been 10 times greater than the one of 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 of which devices to recommend for individual patients on an objective appraisal of their safety and clinical efficacy. The evidence submitted by manufacturers when seeking approval of their high-risk devices must be publicly available, including 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 tackling this field in order to bring new products to the market.

Our team of experienced clinical monitors and project managers work 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.

OPIS regulatory and quality experts can review the available technical documentation to propose directions along the different regulatory pathway to get your medical device registered rapidly and cost-effective.

Available services:

  • 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

OPIS for in Vitro Diagnostics

To date two thirds of all clinical diagnoses are achieved thanks to IVDs. The IVD & companion diagnostic industry is growing rapidly due to several factors, such as high demand for disease testing, especially for infectious diseases as new pathogen strains develop each year, and increased hospital-acquired hospitalization.

With the new European In Vitro Device Regulations (IVDR) that came into force recently, OPIS collaborates with expert consultants in the industry and a team of UNI EN ISO 14155 trained staff to assist clients through challenging clinical compliance matters.

Available services:

  • 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
  • Patient Information and 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

Our clinical and regulatory Teams can adapt to goal the Sponsors have set and help them achieve them before the competition. OPIS can support the Sponsors to ensure their IVDR compliance by May 2022, or, when necessary, transitioning IVD manufacturers from IVDD to IVDR.

Medical Device Experience (Last 2 Years)

Medical Device Ongoing Studies

Contact Us!

Whether you are Sponsor, a Clinical Research Professional or an Investigator contact us to learn more about how we can help.

Request Information
chiama