Global Clinical Development Built To Bring Life-Changing Products to Patients 

Every clinical milestone achieved brings a life-changing product one step closer to the patients who need it. Medicept is a contract research organization delivering end-to-end clinical development solutions on a global scale, from strategy through study closeout, built specifically for medical device and combination product sponsors. 

End-to-End Clinical Support for
Medical Technology Companies

Medical device and combination product clinical development requires more than operational execution. Clinical strategy, regulatory alignment, quality requirements, and evidence generation have to work together from the start. Medicept supports medical devices, digital health, AI-enabled technologies, SaMD, and combination products across every development stage, bringing the right expertise together early enough to reduce rework, strengthen submissions, and keep programs moving forward.

Generate meaningful clinical evidence that supports regulatory and commercialization objectives

Generate meaningful clinical evidence that supports regulatory and commercialization objectives

Access experienced clinical leadership, operational expertise, and specialized medical device knowledge

Access experienced clinical leadership, operational expertise, and specialized medical device knowledge

Align clinical strategy, regulatory planning, quality requirements, and product development goals

Align clinical strategy, regulatory planning, quality requirements, and product development goals

Scale support through full-service or functional service models that flex to your unique needs

Scale support through full-service or functional service models that flex to your unique needs
→ Clinical Strategy & Planning
  • Clinical Development & Strategy
  • Study Feasibility
  • Site Selection
  • Clinical Trial Design and Study Planning
→ Data Management & Clinical Biostatistics
  • Case Report Form Development per CDASH Guidelines
  • EDC, RTSM, ePRO, Design and Validation
  • Data Integrations
  • Third Part Data Imports and Reconciliation
  • Quality Data Review and Query Management
  • Statistical Analysis Plan
  • Statistical Programming and Analysis
→ Functional Service Support
  • Flexible Staffing with Tailored Expertise
  • Scalable Solutions
  • Full Integration with the Project Team
→ Project Delivery
  • Strategic Planning
  • Timeline and Budget Oversight
  • Proactive Risk Management and Mitigation
  • Transparent and Effective Communication
  • End-to-End Execution
→ Clinical Regulatory
  • Clinical Regulatory Strategy
  • Regulatory Submissions (e.g. Pre-submission, IND, IDE, NDA, PMA, 510(k), De Novo)
  • Clinical Trial Application Submissions
→ Clinical Safety & Medical Monitoring
  • Development and Implementation of a Safety Monitoring Plan
  • Reporting and Analysis of Serious Adverse Events
  • Risk Management Strategies to Ensure Participant Safety
  • Safety Data Reporting and Documentation for Regulatory Submissions
  • Medical Monitoring
→ Clinical Trial Management
  • Site Feasibility
  • Site Initiation
  • Site Oversight and Communication
  • Patient Recruitment and Retention
  • Site Support
  • Custom Monitoring Plans
  • Site Monitoring
  • Proactive Risk Management
  • Data Review
→ Clinical Quality Assurance
  • Clinical Audits: BIMO readiness, FDA Inspection Readiness/GCP Audits
  • Quality and Compliance of Processes
  • Identification, Management and Resolution of Quality Events
  • Oversight and Maintenance of the Quality Management System
→ Clinical Medical Writing
  • IDE and PMA Submission Documents
  • Clinical Study/Evaluation Reports

Medical Device & Combination Product Clinical Development Built for Progress

Medical device and combination product clinical trials present unique operational, regulatory, and evidence-generation challenges. Medicept supports clinical strategy and execution across medical devices, and combination products, with therapeutic experience spanning oncology, cardiology, neurology, and other complex medical technologies where evidence generation, patient safety, and outcomes matter most.

We help medical technology companies design and execute clinical studies that generate meaningful evidence, strengthen regulatory alignment, and advance commercialization. Every study we run brings a life-changing technology one step closer to the people who need it.

medical device clinical development

Clinical Solutions Designed Around Your Product Lifecycle

Whether you need an end-to-end contract research organization or targeted expertise to strengthen an existing team, Medicept provides scalable support models that adapt to your clinical development goals.

Full-Service Global Clinical Trials

End-to-end clinical trial management designed for medical device and combination product sponsors. From study planning and protocol development through site management, monitoring, regulatory coordination, data oversight, and study execution, Medicept helps generate meaningful evidence while maintaining alignment with regulatory and commercialization objectives. Explore Full-Service Global Clinical Trials

Full-Service Global Clinical Trials

Functional Service Offerings

Flexible clinical support models that provide targeted expertise where and when you need it most. Medicept helps strengthen internal teams through scalable support across clinical operations, project management, monitoring, clinical data management services, regulatory coordination, and study execution.Explore Functional Service Offerings

Functional Service Offerings

Specialty Clinical Services

Focused clinical expertise for organizations facing unique development, operational, or evidence-generation challenges. Services include clinical strategy, protocol development, post-market studies, trial rescue support, fractional clinical leadership, and specialized consulting tailored to your program needs.Explore Specialty Clinical Services

Specialty Clinical Services

Clinical Development Questions We Hear the Most

What is a medical device CRO?

A contract research organization (CRO) manages clinical trials and study activities on behalf of medical device sponsors. Medicept provides end-to-end clinical trial management and targeted functional support specifically designed for medical devices, combination products, SaMD, and AI-enabled technologies, helping generate meaningful clinical evidence that supports regulatory and commercialization objectives.

How is a medical device CRO different from a pharma CRO?

Medical device trials operate under different FDA frameworks, evidence standards, and submission pathways than pharmaceutical studies. Medicept's team is built specifically for medical technology, with deep experience across 510(k), De Novo, PMA, and Breakthrough Device programs.

When should I engage a CRO?

Early engagement allows clinical strategy to align with regulatory pathway, submission timing, and commercialization goals. Waiting until a study is ready to execute often results in costly protocol revisions and downstream delays.

Can Medicept support part of my clinical program rather than the whole study?

Yes. Medicept offers flexible functional service models that provide targeted expertise across monitoring, data management, regulatory coordination, and clinical operations without requiring a full-service engagement.

Does Medicept support post-market clinical studies?

Yes. Medicept supports post-market clinical follow-up, expanded indication studies, and ongoing evidence generation as part of a product's full lifecycle strategy.

One Partner. More Clinical Progress.

Clinical development doesn't end at study close. Medicept supports organizations across the full product lifecycle, from pre-market strategy through commercialization and post-market obligations, so your program keeps moving forward at every stage.

Explore Our Approach
clinical development consulting
“We selected MEDIcept after extensive due diligence because they could support both our 510(k) submissions and post-market clinical work. Their ability to manage multiple aspects of U.S. market access, combined with their expertise and exceptional quality of work, has kept us coming back.

Having one partner support both the submission and clinical study created valuable continuity and collaboration. The team has remained flexible as our study and FDA requirements have evolved, and Celeste has been an excellent organizer and communicator throughout the process.”
Lifemotion

Michael van Driel, Vice President of Global Business Development and General Manager

Lifemotion Srl

Ready To Advance Your Clinical Program?

Medicept provides the clinical expertise and operational support to move your study forward on time, on strategy, and with confidence. Patients are waiting.