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.
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.
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.
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.
Resources and expertise to identify, generate, synthesize and communicate evidence of treatment value and safety
Expertise to accelerate market access and drive product adoption
Integrated solutions based on the science of imaging biomarkers.
ICON provides a full range of laboratory services that are dedicated exclusively to clinical development.
Transform both organisational flexibility and operational productivity
The third edition of the ISO 14155 guidance outlines standards for the design, conduct, recording and reporting of medical device clinical studies.
Regulatory agencies are relaxing guidelines and shifting priorities in diagnostics and respiratory devices.
Discover how emerging technologies can increase clinical trial efficiency.
Develop the right business strategy to successfully navigate MDR/IVDR.
Is your business strategy in place for a successful transition to the new EU regulations?
How to achieve success in the rapidly-growing value-based market.
Device manufacturers will need to navigate regulatory compliance efficiently and incorporate sophisticated outcome-based compensation models for patient-centric targeted therapies.
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.
How can medical device manufacturers sustain growth and successfully navigate the shift to value-based care in the US?
Cybersecurity vulnerabilities can emerge in any medical device that can be connected to another electronic device or network.
The mobile healthcare technology (mHealth) revolution is driving clinical development and transforming clinical trials and patient care.
Technologies that accelerate and improve clinical trials.
Design for the Patient Experience.
Late phase research, technology solutions and access to RWD are at the forefront of creating efficiencies in all stages of study design and implementation
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.