Many medical device trials today are related to devices used in the treatment of Orthopedic conditions. CROMSOURCE knows how to support your project from the earliest stage to ensure a targeted and efficient study design through to regulatory approval and study delivery. In this way CROMSOURCE supports our clients in helping them provide the data on which evidence-based clinical decisions can be made.
With the experience you would expect from an international organization expert in medical device clinical development, CROMSOURCE guides and manages all aspects of project delivery to ensure effective study design, careful site selection, successful subject enrollment and retention, and diligent site management.
CROMSOURCE’s orthopedic clinical study experience includes the following indications:
- Long bone fractures
- Degenerative disc disease management and replacement
- Osteoarthritis of the knee, hip, and shoulder
- Joint arthrodesis and spine fusion
- Periodontal disease
- Changes to EU Medical Device Legislation: What you need to know - White Paper June 2016
- Clinical Data for Medical Devices - Preparing for increased requirements in the EU - White Paper, 2015
- Medical Device Overview
- Clinical Evaluation Reports - White Paper, 2015
- Wound Closure - White Paper, 2014
- EU Recast of the Medical Device Directives: The Rocky Road to the new Medical Device Regulation - White Paper, 2014
- Language Requirements for EU Medical Device Labels - Multilingual, September 2012