Medical Device Development Expertise

We understand the unique challenges of medical device development: intense competition, precise regulatory requirements and shortened product exclusivity and life cycle. Our highly experienced medical device specialists provide innovative, results-focused support for our clients’ clinical, regulatory and marketing needs.

We dedicate resources to every project, making our medical device development team an extension of our client’s staff. Linking the teams via a customisable suite of secure, Web-based project management tools delivers seamless integration. Our full-service support, customised to our clients’ needs, and our expertise in multiple therapeutic areas maximise the results.

Medical Device Development Expertise

Medical Device Regulatory Expertise

GCR’s extensive understanding of the medical device regulatory landscape helps our clients save time and money with their studies.

Working in partnership with a pre-eminent physician network and experienced consultants, we provide the highest-quality FDA regulatory compliance strategy for medical device development, including:

  • FDA submissions
  • FDA meeting preparation, attendance and follow-up
  • Quality assurance auditing and compliance
  • Quality system design and assessment
  • Employee training and document control

We also can provide clinical regulatory compliance services for medical devices through our European representatives.