Skip to content

MENU

Contact us
Expertise in
Medical Device Testing

We provide analytical testing, risk assessment, and regulatory support to help deliver safe, compliant medical devices to global markets.

hex-image-medical-evices-h2

hex-icon Why Broughton?

Medical Device
Testing Services

See how our GMP and ISO 13485-aligned testing programmes support your device’s safety, performance, and compliance at every stage.

Download our testing capabilities overview

Risk Management
& Toxicology Assessment

Access toxicological evaluations and ISO 14971-aligned risk assessments to support MDR and FDA submissions.


Download our toxicology services guide

Analytical Chemistry
& Method Development

Generate reliable data for compliance and product performance with tailored analytical methods and impurity profiling.


Download our analytical capabilities summary

Regulatory Submission
& Strategy

Learn how we support, CE mark, and UKCA submissions through robust data and regulatory insight.

Download our medical device regulatory roadmap

Post-market
Compliance & Monitoring

Stay compliant with ongoing testing, reporting, and surveillance strategies aligned to ISO 13485 and MDR expectations.

Download our post-market support overview

Clinical & Performance
Evaluation Support

Support device safety and performance claims with evidence from literature reviews, equivalence, and scientific justification.

Download our clinical evidence support pack

hex-icon Building Certainty, One Partnership at a Time

At Broughton, we measure success by the trust our clients place in us. As a global CRO, we work as an extension of our clients’ teams, delivering integrated analytical, scientific, and regulatory services that bring clarity and build certainty across pharmaceutical, healthcare, and lifestyle markets.

Expertise and Certainty in a Complex Regulatory Landscape - “We needed a partner who ensures strict compliance in highly regulated environments. Broughton provided the scientific expertise and operational certainty to help us deliver safe, effective medicines while accelerating our path to market.”

Regulatory Affairs Director, Specialty Pharma Company

A True Extension of Our Team - “In healthcare, balancing innovation with compliance is key. Broughton guided us through moderate regulation with practical insights and responsive support. They’re more than a service provider—they’re a trusted part of our team.”

Head of Product Development, HealthTech Innovator

Trusted Support in Emerging Markets -“In emerging markets, we need agility and credibility. Broughton helped us navigate minimal regulation while maintaining high safety and quality standards. Their insight gave us the confidence to scale faster.”– Innovation Lead, Lifestyle Brand

Head of Product Development, HealthTech Innovator

hex-icon Products We Support

We provide services for a wide range of medical devices, including:

Diagnostic Equipment: Devices such as imaging systems and blood glucose monitors used to detect and monitor medical conditions.

Therapeutic Devices: Technologies including infusion pumps and ventilators designed to treat or manage health conditions.

Surgical Instruments and Tools: Precision instruments used during operative procedures across a range of specialities.

Implantable Devices: Long-term use products such as pacemakers and orthopaedic implants requiring rigorous testing and compliance.

Wearable Health Technology: Connected devices designed for continuous monitoring, data capture, or therapeutic delivery.

In Vitro Diagnostic (IVD) Devices: Laboratory-based tools and kits used for the analysis of biological samples outside the body.
inhaler-v2
hex-image-animal-health-h4

hex-icon Our Expertise

Research and Development: Early-stage scientific input to guide product formulation, safety strategy, and testing design.

Scientific Substantiation: Analytical testing and toxicological assessment to support product safety, efficacy, and regulatory compliance.

Post-Market Compliance: Ongoing testing, documentation, and regulatory support to ensure continued product quality and market readiness.

Our team works as an extension of yours, helping you reduce risk, accelerate timelines, and bring products to market responsibly.

Knowledge Centre

Explore expert insights and technical guidance to support medical device development.

Title of download

Description of downloadable content

Download

Title of download

Description of downloadable content

Download

Title of download

Description of downloadable content

Download

Title of download

Description of downloadable content

Download

Title of download

Description of downloadable content

Download

Title of download

Description of downloadable content

Download