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

Scientific Expertise
Believe for Human Good
Continued Dedication to Current Client Project Contracts
Expertise to Deliver Exceptional Results
Real World Data in Evaluating Device & Patient Safety
XcelTrials in-house trial management solution to improve clinical study outcomes
Led by Passionate Experts to Support Your Clinical Trial Journey at Any Point

Regulatory

CDSCO, EU, EAR, MHRA,TGA, EUDAMED

Clinical Trials

Pilot, Pivotal,PMS and PMCF

XcelTrials

Clinical Trial Management System, eCRF, ePRO,eICF, eTMF

Toxicology

Toxicological Risk Assessment PDE/OEL / ADE Reports Completed 2000 Plus PDE Report

BENEFITS

We'll Ensure You Always get the Best Results

At Bioexcel, we are committed to helping you navigate the complex landscape of clinical trials for Medical Devices.

Our clinical services encompass a wide range of crucial aspects in the development of your Medical Device.

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 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.

Consulting Services

Bioexcel Consulting Services encompass a range of strategic and advisory services aimed at guiding medical device companies in their development and market entry.

Clinical Evaluation Reports

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

Training and Education

Bioexcel’s Training and Education services are designed to empower clients and their teams with the knowledge and skills needed to excel in the complex fields of clinical trials, regulatory compliance…

Scientific and Technical Expertise

Bioexcel’s Scientific and Technical Expertise services offer clients access to a team of highly specialized professionals in various critical fields…

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.

How We Work

A Comprehensive Directory For Your Health Care

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Vision

To support the emerging technology research to get accurate clinical data to diagnose health problem and to deliver value to patients, healthcare systems.

Mission

To empower the creators of Medical Devices,guiding them through every stage of development from concept to Market excellence and focus precisely towards the safety of patients for the well being of society

Core Values

Trust , Team Work , Human Values , Protect & Respect the Human & Animal Subject , Passionate , Integrity , Continuous Development

Phases

Clinical Trials Phases

Biocompatibility

Toxicology & Bio Material , Animal & Cadaver Studies.Toxicology Risk Assessment Biostability And Bioactivity.

Biocompatibility

Toxicology & Bio Material , Animal & Cadaver Studies.Toxicology Risk Assessment Biostability And Bioactivity.

Feasibility and Pilot studies

Pilot studies are small- scale trials that provide additional insights into the devices performance. These studies often involve a small number of participants.

Feasibility and Pilot studies

Pilot studies are small- scale trials that provide additional insights into the devices performance. These studies often involve a small number of participants.

Pivotal

Pivotal phase in Medical device clinical trials, similar to the phase lll trials in drug development aim to provide the critical evidence needed to support the device’s safety and effectiveness for regulatory approval.

Pivotal

Post- Market Surveillance (PMS)

PMS is essential for tracking the device’s performance and ensuring ongoing patient safety involves the continuous monitoring of devices once they are on the market and address safety concerns and adverse events

Post-Market Clinical Follow-up (PMCF)

After regulatory approval, some device may require ongoing clinical follow up to monitor their long- term safety and performance, collect real-world data to ensure the device continues to meet safety and efficacy standards and to identify any potential issues

Human Factors and Usability Testing

For Devices with user interface or human interaction, human factors and Usability testing assess how well users can interact with and operative the device to ensure the device’s usability and safety

Human Factors and Usability Testing

Exploratory studies and Investigational Device Exemptions

In some cases, especially with novel or highly risk devices, exploratory studies or IDEs may be conducted before Pivotal trials. These studies help gather preliminary data to support further development and large trials.

Exploratory studies and Investigational Device Exemptions (IDEs)

SERVICES

FULL SERVICE CONTRACT RESEARCH ORGANIZATION FOR MED-TECH INDUSTRY

Client Focused,Flexible And Also Cost Effective.

Testimonials

What Clients Say About Us

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

"We had the pleasure of working closely with the Bioexcel team on a post-market clinical follow-up project, and I must say, their dedication and expertise were truly impressive. Throughout the project, Bioexcel team demonstrated a deep understanding of regulatory requirements and clinical methodologies, ensuring meticulous data collection and analysis. Their proactive approach to identifying potential issues and implementing effective solutions meant that our project stayed on track and yielded valuable insights efficiently. The team's professionalism and commitment to high standards were evident in every interaction, making them a trusted partner in our clinical research endeavors. I would highly recommend Bioexcel for any organization seeking reliable support in post-market clinical follow-up studies. Their proficiency, reliability, and commitment to excellence make them stand out in the field."

Bibi Hajira A QA Manager - - Surgical Sutures Private Limited

"Good experience to work with Bioexcel’s contract research services, focusing on their skills in regulatory affairs, protocol submission, Report Preparation and work quality. Overall Bioexcel team was supportive and happy and make others happy. Bioexcel’s team had a great understanding of the rules and guidelines, making sure our submission is perfect. Their careful approach to preparing protocols and reports helped us get approvals quickly, which moved our project forward smoothly. The high-quality work they delivered showed their dedication to doing things right. Communication with Bioexcel was easy and effective. The team always responded quickly and worked well with us, which helped us solve problems and make decisions efficiently. Bioexcel’s professional and reliable services played a key role in our project’s success. Kudos to Bioexcel team - Amandeep singh, Jaspal singh, Bharath, Mayuri, and all the rest of the team."

V.Mohanapriya Management Representative - Excellent Hi-Care Private Limited

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

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

"Dear Bioexcel [CRO Team], I wanted to provide some feedback on the PMCF activity recently conducted by your team. Overall, we appreciate the thoroughness and professionalism demonstrated throughout the process. The timely delivery of reports and the quality of data provided were particularly commendable. However, I believe there's room for improvement in terms of communication regarding project updates and milestones. Clearer timelines and more proactive updates would enhance our collaboration moving forward. Thank you once again for your efforts. We look forward to continuing our partnership."

Mr. Avinash PR Manager – Unisur Lifecare Private Limited

" We have been extremely impressed with the dedication and thoroughness demonstrated by Bioexcel Team in their Post- Market Clinical Follow-up activities. The team's proactive approach in engaging with us for feedback is commendable. Their transparency and professionalism have not only enhanced our confidence in their products but have also contributed significantly to our clinical outcomes. I highly appreciate Bioexcel team for their exceptional PMCF efforts. "

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

Firstly, I would like to commend your team for their strong commitment to regulatory compliance. Throughout our collaboration, Bio Excel consistently demonstrated a thorough understanding of FDA and international regulatory standards, ensuring that all aspects. The quality of research conducted by Bio Excel has been exceptional. Your team's expertise in designing and executing robust methodologies has resulted in reliable and insightful data. This has been crucial in informing our product development and regulatory submissions. I have been particularly impressed with BIOEXCEL's project management capabilities. Your team has effectively managed timelines and milestones, keeping us informed at every step of the process. Communication has been another strong suit of BIOEXCEL. Your team has consistently provided clear and timely updates, addressing any concerns or questions promptly. This transparent communication has fostered a strong collaborative relationship and instilled confidence in your ability to deliver results. While our experience has been overwhelmingly positive, I believe there are opportunities for further Collaboration. I would be happy to discuss this further to support BIOEXCEL's continuous improvement efforts. Overall, working with BIOEXCEL has been a valuable experience, and I look forward to continuing our partnership in future projects. Please convey my appreciation to your team for their hard work and dedication.

GET IN TOUCH

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

Get in Touch with us

Services

Clinical Trial Services

Protocol Development
Clinical Trial planning
Site selection and Management
Patient Recruitment and Retention
Clinical Data Management
Biostatistics and Data Analysis
Clinical Trial Monitoring
Medical Writing
Quality-Assurance and Auditing
Project Management
Site training and support
Adaptive Trial Design

CE for all types Medical Device
Medical Device Technical File
Risk Management
Instruction for Use of IFU & labels
CER (Clinical evaluation report)
Product Classification
Test License
Manufacturing License
Import License
Post approval Changes
US FDA 510k
Product Lifecycle Management

MEDICAL DEVICE REGULATION

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

Mail Us

Call Us

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

Regulatory

Clinical Trials

XcelTrials

Toxicology

BENEFITS

We'll Ensure You Always get the Best Results

SERVICES

Services We Offer

Clinical Trials

Biostatistics

Regulatory Affairs

PDE Report

Materiovigilance

Quality Assurance and Compliance

Consulting Services

Clinical Evaluation Reports

Training and Education

Scientific and Technical Expertise

Post-Market Surveillance (PMS and PMCF)

Bioexcel Medical Device Research Organization

Global Medical Device Research Organization

HOME SAMPLING

Diverse technologies with global impact

How We Work

A Comprehensive Directory For Your Health Care

Book an Appointment

Conduct Checkup

Perform Treatment

Prescribe & Payment

Vision

Mission

Core Values

Phases

Clinical Trials Phases

Biocompatibility

Biocompatibility

Feasibility and Pilot studies

Feasibility and Pilot studies

Pivotal

Pivotal

Post- Market Surveillance (PMS)

Post-Market Clinical Follow-up (PMCF)

Human Factors and Usability Testing

Human Factors and Usability Testing

Exploratory studies and Investigational Device Exemptions

Exploratory studies and Investigational Device Exemptions (IDEs)

SERVICES

FULL SERVICE CONTRACT RESEARCH ORGANIZATION FOR MED-TECH INDUSTRY

Testimonials

What Clients Say About Us

GET IN TOUCH

Performed By Highly Qualified & Experienced Team

Clinical Research

Clinical Trial Management

Get in Touch with us

Services

Clinical Trial Services

Clinical Development

REGULATORY

MATERIOVIGILANCE

Contact Details

Other Pages

Make Appointment

Call Us

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