Regulatory

Ensuring success by using valid evidence to tell the story.

regulatory_support_image 2

Regulatory  |  Submissions & Technical Content

A key component in both US and international regulatory submissions is the technical description of the device, its mode of operation and the verification and validation test results.  Medavise has significant experience in preparing technical content for US 510(k) and IDE submissions as well as for Technical Files or Design Dossiers for international submissions and can augment your own resources when needed.  Medavise can incorporate your technical content into complete regulatory filings for Class I and II devices and provide expert assistance for Class III submissions.

Regulatory  |  Clinical Evaluation Report

Every medical device sold in Europe and many other parts of the world, from a Class I through a Class III device, is required to have a Clinical Evaluation Report (CER) in its technical file.  Medavise combines your risk management, clinical and commercial results with the perspective of experienced medical device engineers having extensive backgrounds in technology assessment, device design, risk management, complaint investigation, literature reviews, technical writing and ISO/MDD-compliant CER preparation to write the complete story on your unique device. Our experience includes writing CERs to the new European Commission MEDDEV 2.7/1 revision 4 guideline released in June 2016.

The MEDDEV guideline states that evaluators should be suitably qualified. The Medavise group has a background that includes:

  • Mechanical, electromechanical, chemical and polymer device design
  • Orthopedic, spinal, cardiac, urologic and epidermal-sensor technologies and the conditions they treat
  • Research, preparation and presentation of original work for medical device patents, scientific posters, book chapters and podium presentations at scientific and medical conferences
  • Completion of literature reviews and CERs in all classes of devices, in a variety of fields including orthopedic, gastric and biologic material delivery

Whether your device requires the unique perspective of a technical expert to construct your CER, or you simply need help in meeting your submission deadlines, Medavise provides the thorough, expert literature search and CER preparation your device deserves.

services_icon_small

The client engaged Medavise to prepare a routine update of an existing CER for their spinal implant, which had been written to the MEDDEV 2.7.1 revision 3, in use since 2009. The new CER was updated to meet the requirements of MEDDEV 2.7/1 revision 4, which was issued in June 2006.  Along with revising the layout to match the new MEDDEV recommendations, Medavise created a new appraisal scheme for data relevance and validity to meet the more rigorous requirements of the new revision.   The updated CER included a more detailed demonstration of equivalence to clearly allow the literature search results to be applied to the client’s device.  Additional cross references and citations were added to provide support for investigative methods and analysis.  Additional literature was found to provide the proper context for complaint analysis.  When finished, the updated CER was twice as long as the original – but the additional proof that the evidence was valid created an iron-clad story of the device’s clinical safety and performance.

services_icon_small

The client is a start-up company with a new Class II device in the gastroenterology field and needed a CER to support its CE mark application.  In an area with mature technology, there were numerous published articles presenting Level I and Level II clinical evidence (CBEM model).  While any of these articles would have satisfied the desire for high-quality clinical research to support a positive benefit-risk conclusion, the literature review component of the CER included many articles published in international journals in order to minimize any potential impact of bias on the part of an application reviewer.  The client is now selling the device in multiple international markets.

services_icon_small

Medavise  assisted in the development of technically-oriented marketing materials for a global pharmaceutical firm.  Combining a passion for technology and an engineer’s attention to detail, Medavise identified statements that required attribution from a scientific or regulatory perspective, identified supporting documentation, assisted with proper understanding of the studies being cited, annotated articles and prepared reference matrices to support approval by the client’s Ad/Prom group and regulatory agencies.  Medavise has also written original copy for journal article reprint carriers.  These new marketing materials support a billion-dollar product line used throughout the world.

Success: starting at the beginning and focusing on the basics.Learn More
Ensuring success by using valid evidence to tell the story.Learn More
A strong quality system is the foundation of lasting success.Learn More
Guiding entrepreneurs and start-ups toward their path to success.Learn More