Clinical Blog

We are pleased to announce that we are adding Clinical Trial Services to our Engineering and Regulatory service offerings.  MED has well over 25 years’ experience conducting clinical studies and we are accredited to ISO 14155.  At this time, we are considering concentrating our efforts on smaller scale clinical pilot or feasibility studies, which would be in keeping with our verification and validation testing and development efforts for early stage, novel medical devices.  Our hope is that we are able to help a broad range of clients seeking to help patients and physicians bring new medical products and therapies to the marketplace.

We recognize that when developing a novel medical device, there are frequently times when only human clinical data will suffice to establish proof of concept, or inform improvement of device design.  Early clinical data may be needed to support regulatory submissions, create publications, or simply to advance knowledge of diseases and associated treatments.  MED Institute can help with design and conduct of early feasibility clinical trials to meet these needs.  Our ability to conduct early feasibility clinical trials will closely complement our current service offerings of device design and development, and non-clinical verification and validation testing. Our intimate knowledge of your device will enable us to design clinical trials crafted to answer the most pertinent questions.

Our expert clinical personnel backed by our regulatory team can help you and your team design and conduct efficient, successful clinical trials that will meet regulatory requirements. Services include the following, as needed:

  • Document preparation for Institutional Review Board submission
  • Document preparation for regulatory applications (e.g., IDEs or CTAs)
  • Clinical trial protocol development
  • Clinical trial imaging consulting
  • Clinical trial site assessment
  • Clinical trial site training and support
  • Case report form/database creation, implementation, and management
  • Clinical trial reporting and final data output
  • Exceptional customer service

The Clinical team at MED Institute can help you decide when clinical data may be necessary, how to collect the data most efficiently, and can apply significant experience to executing your trials.

What Should You Do When a Testing Standard Doesn’t Exist? Part 1: Introduction

This is the first part in a six-part series that will help explain your options.

When a company has a new design for a medical device, appropriate testing is essential to demonstrate the safety and effectiveness of the device for its intended use. It is convenient when there is an applicable testing standard, but that is not always the case.

OMTEC Part 1_ASME    OMTEC Part1_ASTM    OMTEC Part 1_AAMI.png   OMTEC Part 1_ISO.png

Medical device technology typically advances more quickly than the creation of standard test methods; therefore, many medical device industries have a limited number of standard test methods available for their use.

Without a standard test method in place for a particular type of device, there is an increase in risk. Risk for the patient, risk for the regulatory body and financial risk for the medical device company.

When a suitable testing standard is unavailable, you have the following options:

  • Work with the standard organizations to develop a test method.
  • Develop and validate a new test method and gain FDA agreement.
  • Approach a third party to build testing equipment to allow the standardization of the test method.
  • Form an industry consortium to develop consensus.

In the next part of this series, we’ll look at how you can partner with the standard organizations to develop a test method.

For more information, please visit our website at

sign up