Providing comprehensive services to the med tech industry

Medical Device and Diagnostic Development

Access global regulatory expertise across every stage of med tech product development.

Partner with an experienced, dedicated medical device and diagnostic development team.

ISO 13485 certification: reducing your oversight and audit requirements.

Regulatory expertise, clinical experience and quality certification.

The requirements needed to develop medical devices and diagnostic products—and successfully bring them to market—continue to evolve. This necessitates a deep knowledge of the evolving regulatory environments globally and a keen understanding of efficient and effective trial design to achieve your goals. Drawing from our experience advancing more than 740 device and diagnostic trials run in the last five years, our team at Fortrea is ready to help.

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Advance life-changing medical devices from concept to approval.

Our team of medical device, imaging and drug-device combination specialists can provide consulting to support your:

Global regulatory submissions, including Clinical Evaluation Reports (CERs)
Protocol development
Global clinical trial design and execution
Post-market studies
Design control support

Medical Device Development

Accelerate IVD development with global clinical validation services.

Our experienced diagnostic development team supports the development of in vitro diagnostics (IVDs), companion diagnostics (CDx) and liquid biopsy advances. Our solutions include:

Regulatory consulting and submissions, including extensive IVDR experience, to ensure you meet new and existing regulatory requirements
Analytical support and clinical validation studies
Access to diverse and rare patient samples
Advanced data-driven site selection, location and study timing insights to successfully recruit within your specified window

In Vitro Diagnostic Development

Our collaboration delivers product value.

Across the world, we are supporting visionaries to accurately and safely bring new life-changing options to market. This effort places a sharp focus on prioritizing the value of your product and highlighting its advantage in a competitive marketplace.

We work as an extension of your team, so you can expect:

A trusted partnership with an experienced, dedicated medical device and diagnostic development team of more than 150 regulatory, clinical and market access experts
The backup of a global CRO, with extensive site networks and resources
Especially deep expertise in diagnostic, cardiovascular, metabolic, oncology, neuro, pulmonary/respiratory, ophthalmology and imaging study design and execution
Complete support across the medical device and diagnostic development journey
Global regulatory support from preclinical and clinical development phases to reimbursement strategies and commercialization

Work with a partner invested in your success.

Our team has invested in key certification standards such as ISO 13485 to help minimize audit complexity and maximize quality compatibility throughout development. And, as with any high-performance team, we strive to form an interactive relationship to achieve greater results together.