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Title of the document Bioexcel Medical Device Research Organization
(MDRO)

  • Comprehensive Expertise in Medical Research
  • Commitment to Advancing Healthcare
  • Dedicated Client Success Management
  • Excellence in Data-Driven Results
  • Real-World Evidence for Patient Safety
  • XcelTrials: Our In-House Trial Management System
  • Expert-Led Clinical Trial Support
Quality Assurance

Global Regulatory Expertise for Seamless Approvals

Expert guidance for CDSCO, EU MDR, MHRA, and TGA approvals, including EAR & EUDAMED registration.

Comprehensive Clinical Trial Management

Comprehensive clinical trial solutions covering pilot, pivotal, PMS, and PMCF studies to drive your medical device’s success and regulatory approval.

Comprehensive Toxicology Assessments

Expert support for CDSCO, EU MDR, MHRA, TGA, EAR & EUDAMED approvals

Streamlined Clinical Trial Management with XcelTrials

Leverage our in-house Clinical Trial Management System (CTMS) with features like eCRF, ePRO, eICF, and eTMF to enhance trial efficiency and outcomes

BENEFITS

Your Partner for Reliable Clinical Trial Success

“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.

Key Highlights

ISO-Certified Excellence

 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.

SERVICES

Services We Offer

Clinical Trials

Feasibility, IRB/IEC Communication, Study StartUp, Monitoring, Auditing & Biostatistics

Biostatistics

In House Software For Statistical Analysis, Sample Size Calculations, Statistical Reports

Regulatory Affairs

EU proposed Extension of MDR transition CE for Medical Device, 510K, CDSCO.

PDE & OEL Report

Experienced & Certified ERT / DABT
Toxicologist for PDE Reports & Review.     

Materiovigilance

Medical Device Vigilance Medical Device- Associated Adverse Event PMCF, PSUR.

Quality Assurance and Compliance

Critical for ensuring that medical devices meet high-quality standards.

In Vitro Diagnostics solution

IVDR Services: Navigating Clinical Performance for IVD devices comply with the stringent requirements of the EU (IVDR 2017/746). 

Clinical Evaluation Reports

Bioexcel assists clients in preparing thorough and well-documented reports that serve as essential components in the regulatory

Biocompatibility Testing

At Bioexcel, we provide end-to-end biocompatibility testing solutions tailored to meet the requirements of ISO 109931:2018, FDA, and EUMDR.

Startup Services

Bioexcel’s dedicated startup services are specifically designed to support innovators at every stage of their journey.

Post-Market Surveillance (PMS and PMCF)

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…

Bioexcel Medical Device Research Organization

Global Medical Device Research Organization

Guiding Medical Devices to Market Excellence

HOME SAMPLING

Diverse technologies with global impact

Bring to the table win-win survival strategies to ensure proactive domination and at the end of the day.

VISION

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.

MISSION

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.

CORE VALUES

Trust, Teamwork, Human Values, Ethical Standards, Passion, Integrity, Continuous Development.

Phases

Therapeutic Areas We Work In

Cardiology

Advancing heart health through research and trials for stents, pacemakers, cardiovascular monitoring devices, and minimally invasive technologies.

Cardiology

Cardiac implants, Heart rhythm management devices, Diagnostic imaging tools for cardiovascular health.

Orthopedics

Innovating orthopedic solutions through trials for joint replacements, prosthetics, trauma implants, and regenerative therapies

Orthopedics

Bone implants and fixation devices, Spinal implants and devices, Sports medicine and rehabilitation solutions.

Neurology

Pioneering neurological care with trials for neurostimulators, brain monitoring devices, and therapeutic interventions for cognitive and movement disorders.

Neurology

Neuromodulation devices, Stroke and brain injury diagnostic devices, Devices for Parkinson’s, epilepsy, and Alzheimer’s

Oncology

Pioneering neurological care with trials for neurostimulators, brain monitoring devices, and therapeutic interventions for cognitive and movement disorders.

Oncology

Biopsy and diagnostic imaging device, Radiation therapy systems, Cancer detection IVDs

Ophthalmology

Enhancing vision care with trials for intraocular lenses, glaucoma devices, and diagnostic imaging solutions for ocular health

Ophthalmology

Biopsy and diagnostic imaging devices, Radiation therapy system, Cancer detection IVDs

Respiratory Care

Improving respiratory health through studies on devices for ventilation, oxygen therapy, and diagnostic systems for lung conditions

Respiratory Care

Respiratory support systems, Inhalers and nebulizers, Sleep apnea management devices
SERVICES

FULL SERVICE CONTRACT RESEARCH ORGANIZATION FOR MED-TECH INDUSTRY

Client Focused,Flexible And Also Cost Effective.

Testimonials

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."

Mr. Parveen Khurana Managing Director - Switz Neubio India Pvt. Ltd.

"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!"

Bibi Hajira A QA Manager - Surgical Sutures Private Limited

"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."

Dr. Anup K. Mamgain Sr. General Manager: TI Medical Pvt. Ltd

"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."

Mr. Avinash PR Manager – Unisur Lifecare Private Limited

"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."

Mr. Nirav Khunt Technical Director - EON Meditech Pvt. Ltd.

"On time response ,on time delivery of reports and good supportive team." Text

V.Mohanapriya Management Representative - Excellent Hi-Care Private Limited
Trusted by 100+ global clients
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Clients across 20+ countries
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Toxicology reports completed
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Easily managed clinical trials
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Performed By Highly Qualified & Experienced Team

Clinical studies as per ICH GCP & ISO 14155

Clinical Research

Hope for Better Tomorrow

Clinical Trial Management

One Stop Solution for Trial Management

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Services

Clinical Trial Services

Clinical Development Services for Medical Devices

End-to-end clinical trial solutions to fast-track your medical device to market
  • Trial Design & Planning
  • Protocol Development
  • Adaptive Trial Design
  • Clinical Trial Planning & Monitoring
  • Site Selection and Management
  • Execution & Monitoring
  • Patient Recruitment and Retention
  • Site Training and Support
  • Quality Assurance and Auditing
  • Data Analysis & Reporting
  • Clinical Data Management
  • Biostatistics and Data Analysis
  • Medical Writing

Regulatory Compliance & Licensing Support

Effortless regulatory services for CE, FDA, and manufacturing licenses
  • Device Documentation
  • Technical File Preparation
  • Clinical Evaluation Reports (CER)
  • Instruction for Use of IFU & labels
  • Licensing & Classification
  • Manufacturing License
  • Test License
  • Product Classification
  • Import License
  • Global Approvals
  • CE Marking for All Device Classes
  • Post-Approval Changes
  • US FDA 510(k) Submissions

Materiovigilance & Post-Market Surveillance

Real-time device safety and compliance with expert post-market surveillance and risk management.
  • Narratives preparations
  • Manufacture Incident Reports
  • Post- Market surveillance Plan
  • Customer Complains
  • Medical device reporting
  • Risk Management
  • PMCF Plan & Evaluation Report
  • Post Market Surveillance Report
  • Adverse Device Effect
  • Field Safety Corrective action
  • Case Processing & follow up
  • Medical Device Incident