At Bioexcel, we understand that clinical trial for medical devices require a unique approach. Unlike multi-phase drug or vaccine development, medical devices demand tailored clinical evidence to demonstrate safety, performance, and usability. As a specialized Contract Research Organization (CRO) for medical devices, we provide comprehensive trial management services that help you navigate the complexities of global regulations and bring your innovations to market.
How Bioexcel Stands Out as a Medical Device CRO
Medical device trials differ significantly from drug or vaccine trials. Instead of multi-phase clinical development, devices require clinical evidence to assess performance, safety, and usability under real-world conditions. Here’s how Bioexcel is uniquely positioned to support medical device manufacturers:
Custom Strategies for Accurate Results
We design device-specific protocols that align with your objectives, intended use, and regulatory requirements.
Key Features:
Laying the Foundation for Trial Success
We identify suitable sites and investigators with expertise in device-specific trials to ensure optimal trial execution.
Key Features:
Streamlining Approvals for Trial Initiation
Our team ensures your clinical trial meets global compliance standards with precise and timely submissions.
Key Features:
Ensuring Long-Term Safety and Compliance
We design and execute PMCF studies to monitor device safety and performance in real-world conditions post-approval.
Key Features:
Challenge:
A manufacturer of a premium intraocular lens (IOL) needed to validate visual outcomes and patient safety in a multicenter trial.
Solution by Bioexcel:
Outcome:
Challenge:
A company developing a Class III knee implant required a trial to assess biomechanical performance and patient outcomes.
Solution by Bioexcel:
Outcome:
Challenge:
A startup producing antibacterial-coated sutures needed clinical evidence comparing infection rates with traditional sutures.
Solution by Bioexcel:
Outcome:
Challenge:
A manufacturer needed to validate the safety and efficacy of a topical hemostatic agent for use in vascular surgery.
Solution by Bioexcel:
Outcome:
Specialized Device Expertise
Experience in Class I, II, III devices, including IVDs and combination products.
Regulatory Mastery
Extensive knowledge of ISO 14155, MDR, FDA, and CDSCO requirements.
Real-World Focus
Expertise in collecting clinical evidence for device performance, usability, and safety.
Global Reach
Proven success in managing multicountry trials with diverse patient populations.
Medical device trials focus on demonstrating safety, performance, and usability rather than pharmacokinetics or dosing, as in drug trials. Device trials also often involve fewer phases but require iterative design validation and real-world testing.
Yes, we have extensive experience managing multicountry trials, ensuring seamless coordination and regulatory compliance across regions.
We adhere to ISO 14155, FDA, MDR, and ICH-GCP guidelines, ensuring all trials meet the highest ethical and regulatory standards.
At Bioexcel, we bridge the gap between innovation and market success with tailored clinical trial services for medical devices. Contact us today to ensure the safety, performance, and compliance of your device.
TO BREAK THE BARRIERS OF TRADITIONAL CLINICAL INVESTIGATION FOR MEDICAL DEVICE INDUSTRY
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