|
|
Company Description: |
|
MED Institute, Inc. was incorporated in 1983 to identify and develop new medical product concepts. From investigating a new concept to product marketing, MED provides a continuum of services to support the medical product manufacturer. In the product development process, MED Institute offers research, product design, prototyping and testing (feasibility and GLP) needed for the evaluation of new products. MED laboratories include a technology assessment lab, an advanced histology lab and biomechanical fatigue analysis lab. MED also coordinates clinical research worldwide and FDA and foreign regulatory approvals. Medical technology transfer through scientific presentations and product publications, product information, and technical training are central to high technology product development at MED Institute. MED Institute was established as a resource for COOK Group companies to identify and develop new medical product concepts. This includes new product identification, prototype development, nonclinical Good Laboratory Practice testing, clinical trial management and data analysis, education for the medical community, and preparation of regulatory submissions. MED Institute employs a staff of research, medical, engineering, and technical personnel or professionals. MED Institute has established a Quality Management System that has been certified to ISO 13485 and conforms to ISO 14155. In addition, the MED Institute Laboratory has a number of tests accredited to ISO 17025 (see web site for details) |
|
Services provided by category: |
|
Biostatistics, Clinical Monitoring, Clinical Trial Data Management, Clinical Trial Design, Clinical Trial Management, Clinical Trials, Contract Research, Data Management, Electronic Data Capture, GLPs, IND/NDA Submissions, Investigator Recruitment, Nonclinical Research, Phase I Clinical Trials, Phase II Clinical Trials, Phase III Clinical Trials, Phase IV Clinical Trials, Post-Marketing Safety, Preclinical, Regulatory, Regulatory Guidance, Regulatory Submission |
|
|
|
|
