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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Decoding AI in software as a medical device (SaMD)

Regulatory insights and market strategies.

This whitepaper provides a starting point for medical device researchers considering use of AI in SaMDs. Understanding the FDA regulatory requirements and guidance on submissions can enable medical device researchers to plan their route to market and avoid potential obstacles on the way.

Clinical strategies to optimise software as a medical device (SaMD) for treating mental health

Read our comprehensive guide for navigating the complexities of clinical investigations involving SaMD in mental health, offering strategies to optimise clinical trials while adhering to ethical, regulatory, and technological standards.

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.

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.

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.

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?

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: