Medical devices are a unique field with a unique approach to regulatory approvals and clinical trials. Biorasi combines deep expertise in the specialized area of medical devices, and combines it with decades of therapeutic area excellence and our industry leading processes to make your device journey from idea to market as easy as possible.

Focus on Medical Devices

Accelerating the medical device development and approval process takes a special kind of contract research organization. It requires an in-depth understanding of the unique regulatory challenges that devices must overcome and a strong scientific and engineering foundation. It requires anticipating risks, and taking steps to preempt them before they turn into problems. Biorasi has the experience and the talent to accelarate your device trial, and be your trusted medical device CRO partner.

A True Medical Device Expert

What are the common issues medical devices face when seeking regulatory approval? Does my device even need regulatory approval? Can it be approved in multiple venues simultaneously? What if my device is a drug/device hybrid?

At Biorasi, we hear questions like these all the time from medical device companies seeking to get their product to market in the United States and abroad. We’ve spent a lot of time, and enlisted a lot of the top experts in the field, to come up with the best answers for our clients and make the device approval proccess as simple and painless as possible. As a true medical device CRO, we offer more than just plans and proposals: we offer answers, and the peace of mind that comes with knowing your device trial is in good hands.

Some of our medical device approval services include:

  • Medical device program development consulting
  • Regulatory consulting for medical devices
  • Multi-venue medical device approval plans
  • Medical device clinical trial management
  • Drug/Device hybrid clinical trials

"One of the rarest events, where we had to communicate [to Biorasi] to stop the screening rather than boost it."

VP of Global Clinical Development, Top Specialty Pharma

Latest News and Blogs

Not Enrolling Enough? How to Rescue Your Recruitment Strategy

A common issue regarding “faltering” studies – studies that are not satisfying their time, cost, and quality parameters – is poor recruitment. Recruitment issues can delay deadlines and jeopardize the drug’s ultimate approval, if left unresolved. These delays are a...

Avoiding the Blame-Game in Rescue: Don’t Ask Who, Ask Why

Introduction Clinical trial rescues can often be a delicate topic for both sponsor and contract research organization. When a study goes off track, it’s natural to want to point fingers and look for who is to blame. However, performing a comprehensive root cause...

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