Medical Device and Diagnostics

Medical Device and Diagnostics CRO Services

For most medical device companies, outsourcing to a CRO is an obvious strategic decision – allowing you to focus on your core strength of developing devices, instead of layering in the complexities of managing and implementing clinical trials.

The Medelis team has extensive expertise in navigating regulatory strategy pathways, classifications, and registration requirements. Medelis is experienced in clinical program execution and product development, which paired with our expansive site relationships and knowledge of established processes and systems gives Medelis the capability of handling the unique demands of medical device and diagnostics submissions and clinical trials. Our partner-like focus allows Medelis to offer the support and expertise that start-up and medium sized medical device companies will need to succeed in their applications.

Our team has worked in a broad range of medical device and diagnostic product studies in the following indications:

  • Oncology
  • Hematology
  • Pathology
  • Microbiology
  • Dental
  • Cardiovascular
  • Orthopedics
  • Nephrology
  • Respiratory
  • Endocrinology/Diabetes management
  • CNS – including pain & psychiatry
  • Dermatology

With Medelis, our partner-like approach grants a depth of transparency, experience and expertise to successfully deliver your study on time and on budget. Our team’s device and diagnostic product experiences have covered Class I to III devices and include:

  • Drug delivery & drug-device combination products
  • Companion diagnostics and IVDs
  • Medical device and software
  • Surgical tools and systems
  • OTC and consumer products

Tell Us About Your Medical Device or Diagnostic Study

Reach out to learn more about how our partnered approach, experience, investigator relationships, bid transparency and flexibility deliver success for our clients in bringing their medical devices and diagnostics to market.

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