Leverage our in-house Clinical Trial Management System (CTMS) with features like eCRF, ePRO, eICF, and eTMF to enhance trial efficiency and outcomes
“At Bioexcel, we simplify the complex clinical trial journey for medical devices, ensuring compliance, safety, and excellence every step of the way.”
“Our services cover all critical aspects of clinical trials, from feasibility studies to post-market surveillance, ensuring the seamless development of your medical device. With globally recognized certifications and a commitment to quality, we are your trusted partner in innovation and compliance.”
Learn how we can help you succeed. Click below to explore our services.
ISO 9001: 2015 – Quality Management System
ISO 14155: 2020 – Clinical Investigation of Medical Devices
ISO 20916: 2019 – In Vitro Diagnostic Medical Devices Performance
ISO 27001 :2022- Standards for information security management and compliance evaluation.
IVDR Services: Navigating Clinical Performance for IVD devices comply with the stringent requirements of the EU (IVDR 2017/746).
Bioexcel assists clients in preparing thorough and well-documented reports that serve as essential components in the regulatory
At Bioexcel, we provide end-to-end biocompatibility testing solutions tailored to meet the requirements of ISO 109931:2018, FDA, and EUMDR.
Bioexcel’s dedicated startup services are specifically designed to support innovators at every stage of their journey.
Bioexcel Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) services are vital for ensuring the ongoing safety and performance of medical devices in the post-market phase…
Guiding Medical Devices to Market Excellence
Bring to the table win-win survival strategies to ensure proactive domination and at the end of the day.
Driving innovation in emerging healthcare technologies by delivering precise clinical data to diagnose health challenges and provide value to patients, healthcare providers, and systems worldwide.
To empower medical device innovators by providing end-to-end support throughout the development journey from concept to market excellence. Our focus remains on ensuring safety, precision, and improved outcomes for patients and society at large.
Trust, Teamwork, Human Values, Ethical Standards, Passion, Integrity, Continuous Development.
Client Focused,Flexible And Also Cost Effective.
What Clients Say About Us
"Working with Bioexcel on a post-market clinical follow-up project was a great experience. Their expertise in regulatory requirements and proactive problem-solving ensured smooth execution and valuable insights. Bioexcel’s professionalism and commitment make them a trusted partner. Highly recommended for clinical research support."
"Bioexcel’s team, including Amandeep Singh, Jaspal Singh, Bharath, and Mayuri, provided excellent contract research services. Their expertise in regulatory affairs and report preparation ensured smooth project progress with quick approvals. Professional, reliable, and efficient—Bioexcel played a key role in our success. Highly recommended!"
"Dear Bioexcel Team, We appreciate the thoroughness and professionalism of your work on the PMCF activity. The timely report delivery and data quality were excellent. However, clearer communication and more proactive updates on project milestones would improve future collaboration. Thank you for your efforts, and we look forward to continuing our partnership."
"We’ve been impressed with Bioexcel’s dedication and thoroughness in Post-Market Clinical Follow-up activities. Their proactive engagement, transparency, and professionalism have boosted our confidence and contributed significantly to our clinical outcomes. We highly appreciate their exceptional PMCF efforts."
"Bioexcel’s commitment to regulatory compliance, quality research, and effective project management has been outstanding. Their clear communication and timely updates fostered strong collaboration. I look forward to continuing our partnership and exploring further opportunities. Thanks to the team for their dedication."
Clinical studies as per ICH GCP & ISO 14155
Hope for Better Tomorrow
One Stop Solution for Trial Management
TO BREAK THE BARRIERS OF TRADITIONAL CLINICAL INVESTIGATION FOR MEDICAL DEVICE INDUSTRY
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