Medical Device Clinical Trials with Precision and Expertise

Comprehensive Support: Clinical Trials for Medical Devices

At Navitas Life Sciences, we provide stellar medical device clinical trial solutions, leveraging our deep expertise across multiple therapeutic areas. Our dedicated team is here to guide you through all medical device clinical trial phases. From designing and implementing trials to managing regulatory compliance, we streamline the entire process, ensuring your devices, diagnostics, and combination products reach the market swiftly and successfully.

Innovating as a Medical Device CRO

Our comprehensive suite of services for clinical trials for medical devices includes device testing, regulatory support, quality consulting, and clinical research, all tailored to meet the unique needs of your project. With over 30 years of experience managing successful clinical trials, our expert team is equipped to handle even the most specialized requirements. Powering possibilities to guide your medical device product from concept through commercialization with efficiency, precision, and compliance.

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The essence of our Medical Device clinical trials solutions include:

Strategy
Strategic guidance tailored to support medical device development, including comprehensive risk management support, expert regulatory compliance consultation, and efficient registration and licensing assistance.
Subject Matter Experts (SME)
Subject Matter Experts (SME)
Our team of medical and scientific SMEs offer exceptional operational leadership with deep therapeutic knowledge.
Regulatory Agencies
Regulatory Agencies
Rigorous regulatory process support, ensuring your medical devices meet necessary standards, including for USFDA, European Commission, WHO, ISO.
Regulatory Processes
Regulatory Processes
Pre-Market approval (PMA) including for FDA: 510(k) clearance or PMA, CE Marking for EU market. Post market surveillance include adverse event reporting, quality system regulation (QSR) compliance, materiovigilance, and more.
Quality Systems
Quality Systems
Adherence to quality management systems (QMS) including ISO 13485: Quality management for medical devices, and FDA QSR: Quality System Regulation.

On-Demand Webinar

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EU Medical Device Regulation (MDR) requirements

Join our Subject Matter Experts as they discuss the impact of EU MDR on Device and Combination Product Surveillance and Labeling.

Brochure

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Successfully integrating Combination Products and Medical Devices

Find out about proactive cross-functional governance and organisation, aligned drug and device processes, and forward-looking UDI and IDMP integration.

Whitepaper

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Streamlined Consulting Complaints Management in Medical Devices

Gain key insights on the medical device industry and inadequate product complaint handling which accounts for a large percentage of FDA inspection findings.

Extensive Experience in Managing Efficient Clinical Trials

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Years of Experience
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Phase I-IV Clinical Trials
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On-time
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Regulatory compliance

Gain the Navitas Life Sciences Edge

Global Presence

Global Presence

Expert support available in North America, EU, and Asia Pacific.
Diverse Experience

Diverse Experience

Handling phases I to IV and beyond.
Proven Benefits

Proven Benefits

Streamlined processes, reduced costs, optimized outcomes.
Tailored Solutions

Tailored Solutions

Customized support for unique trial needs.
350+ Clients

350+ Clients

Repeat business from 90% of clients with multiple years of engagement.

BLOGS

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3 Decades of Supporting Efficient Clinical Trials

Clinical trials are the backbone of modern medical advancements, driving the development of new treatments and therapies that improve patient lives.
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‘Outstanding’ Regulatory Compliance Services to a Top 10 Global Pharma

A leading global pharmaceutical company commended our support as "Outstanding," highlighting our collaborative approach and teamwork in the successful migration of regulatory files.
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Power of Pharma Networking: Peer-to-Peer Networks Drive Insights and Growth

Peer to peer networking can markedly improve understanding about the ever-evolving landscape of pharmaceuticals, with key insights including for Medical Device clinical trials.

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