Global medical device and diagnostic expertise

Device & Therapeutic Expertise

Our dedicated medical device and diagnostics team has the experience, knowledge and flexibility to meet the unique challenges faced by both emerging and established manufacturers throughout the product lifecycle.

Clinical Operations

Global expertise and resources to design, manage and monitor medical device and diagnostics clinical projects from first in human through large scale post marketing programmes.

Regulatory Affairs & Quality Assurance

Our regulatory and quality experts have extensive experience in working with medical devices, in-vitro diagnostics (IVDs), companion diagnostics and combination drug-device products and will help you achieve compliance in your chosen market(s) quickly and cost effectively.

As global regulatory landscapes shift and the convergence of the drug and device industries evolve, our dedicated team at ICON can assist with all phases of your clinical trial development and testing by supporting you in designing, implementing and managing clinical trials for your devices, diagnostics and combination devices, to successfully bring your product to market, faster.

Clinical Research Services

ICON has deep experience with the development and commercialisation of medical devices, medical device software, and in-vitro diagnostics covering all key therapeutic areas and indications.

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Commercial Positioning

Integrated solutions to position your product for global success

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Medical Imaging

Integrated solutions based on the science of imaging biomarkers.

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Central Laboratories

ICON provides a full range of laboratory services that are dedicated exclusively to clinical development.

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FSP & Strategic Resourcing

Transform both organisational flexibility and operational productivity

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Demystifying EU CTR, MDR and IVDR

Submission strategies for clinical trials involving medical devices and in vitro diagnostic devices

Navigating FDA Medical Device Regulations

Episode 1: Warning letters and recalls

Hear our Medical Device experts explore FDA warning letters, recalls and the benefits of early clinical and regulatory engagement in this informative podcast.

EU MDR and IVDR transition extension: What changes do you need to know about?

Read this briefing document to understand the MDR amendment, including transition period extension and conditions and the current status of IVDR.

Patient centricity in insulin injection: Using technology to improve self-administration

David T. Novotny considers the current and future developments in injection technology.

Assessing the need for primary supporting clinical evidence or post-market clinical follow-up under MDR

Discover why identifying the study objective during the planning process for PMCF studies is a critical step in the transition to MDR.

The IVDR Journey

A roadmap to meet 2022 deadlines, while navigating pandemic disruptions

Addressing Cybersecurity for your Medical Device

Cybersecurity vulnerabilities can emerge in any medical device that can be connected to another electronic device or network.

ISO 14155: Increased emphasis on clinical data continues to trend for medical device regulations

The third edition of the ISO 14155 guidance outlines standards for the design, conduct, recording and reporting of medical device clinical studies.

Navigating the “new normal” during COVID-19: A regulatory and clinical perspective

Regulatory agencies are relaxing guidelines and shifting priorities in diagnostics and respiratory devices.

Reimagining the Patient-Centric Clinical Trial with IoMT

Discover how emerging technologies can increase clinical trial efficiency.

MDR and IVDR: Is your business prepared?

Develop the right business strategy to successfully navigate MDR/IVDR.

MDR/IVDR brings higher costs & bottlenecks

Is your business strategy in place for a successful transition to the new EU regulations?

Enhancing Medical Device development returns under Value Based Health Care

How to achieve success in the rapidly-growing value-based market.

The future of device developers in precision medicine

Device manufacturers will need to navigate regulatory compliance efficiently and incorporate sophisticated outcome-based compensation models for patient-centric targeted therapies.

Transforming the R&D Model to sustain growth

Read the white paper, Transforming Medical Device Development: Achieving challenging mandates for cost savings and pipeline productivity, to unlock key strategies for maximising value from your strategic partnerships.

Thriving in Value-Based Healthcare: A guide for cardiovascular device manufacturers

How can medical device manufacturers sustain growth and successfully navigate the shift to value-based care in the US?

How mHealth can transform medical product pipelines into the patient care continuum.

The mobile healthcare technology (mHealth) revolution is driving clinical development and transforming clinical trials and patient care.

Digital Disruption

Technologies that accelerate and improve clinical trials.

Patient Centricity

Design for the Patient Experience.

Real World Data

Late phase research, technology solutions and access to RWD are at the forefront of creating efficiencies in all stages of study design and implementation

Adaptive Design clinical trials

An adaptive design clinical trial can help to create a stronger value proposition for your medical device by reducing development costs and accelerating time-to-market.

Focused on the unique needs of device clients, our experienced teams and technologies are there to help you throughout your study. You will be supported by: