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

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.

Book an Appointment
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore
Conduct Checkup
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore
Perform Treatment
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore
Prescribe & Payment
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore

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.

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

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)