Medical Device Qualified Supplier Directory
MED Institute, Inc. Company Profile
Qualifications: ISO 13485, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: North America
Medical device testing and regulatory submission pathways:
MED Institute’s experience grows as the need for new medical technology increases. To date, MED Institute has worked on projects in more than 40 different medical specialties and been involved in the development of devices ranging from advanced endovascular products to peripheral stents, from gastroenterological products to urological devices and more. MED Institute is a Cook Group Inc. company that has more than 30 years of experience in medical device testing, data analysis, clinical research and global regulatory submission preparation.
MED offers more than 200 accredited medical device testing methods and works diligently to design the right test matrix for each project. MED actively works with international standards committees and regularly consults with regulatory, industry and medical experts.
Some of the tests MED offers are:
- SEM Investigation and Energy dispersive x-ray spectrometry (EDS)
- Physical Bench Measurements and Examination
- Radial Force Testing
- Electrochemical Corrosion Testing
- Immersion Corrosion Testing
- Tensile and Compression Testing
- Torque Testing
- Particulate Matter Counting and Sizing
- Electrosurgical Accessory Testing
- Fatigue Testing
- Flow Testing
- Securement Testing
- Physiological Models and Boundary Conditions Testing
- Radiopacity Testing
- Crush Resistance and Local Compression Testing
- MR Safety Testing: Our testing team is one of few that can help companies determine if their metallic, implantable devices are safe, conditionally safe or unsafe in the MR environment.
- Computer Aided Engineering: Our team offers multiple analysis capabilities such as finite element analysis and computational fluid dynamics and MR simulation.
Global Regulatory Submissions
MED also has extensive experience in global regulatory submission preparation with familiarity in:
- Reclassification petitions
- Submission issue meetings
- Panel preparation and support and more.
We want to collaborate with people who feel as much excitement and possibility in new product ideas as we do. Contact us today to find out how we can help your product dream become reality.
For more information contact MED Institute, Inc.