MED Institute is a resource for COOK companies covering the entire spectrum of the medical device development process, backed by a certified Quality Management System.
Nonclinical and clinical research is performed seeking information and knowledge with the potential to impact future medical devices for the benefit of patients.
Researchers work with academic and industrial partners to develop research into dependable technologies that are the basis for new medical devices.
Cook products are developed over a wide range of technologies. The FDA and ISO13485 compliant design control system includes risk management, requirements analysis, design of mechanical, chemical, electrical, and software components, design verification, and validation.
Formal Nonclinical and ISO17025 Testing
Formal testing to FDA GLP regulations is performed. The testing often involves method validations, and generates formal reports suitable for including with regulatory submissions. Bench, in-vitro and in-vivo facilities are available.
Production processes are developed and validated. Many semi-automated machines for production processes with validated software, full documentation, training, and support have been developed.
Product development and pre-clinical testing are performed with strategies in mind of how to best support the regulatory process for medical devices. A full range of regulatory applications are filed worldwide.
Clinical Research Organization
Clinical trials are conducted ranging from small feasibility studies to multi-center, multi-national pivotal studies. Steps include protocol development, clinical site initiation, clinical site monitoring, data collection, data validation, data safety monitoring, and data analysis.