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Expertise in
Medical Device Testing

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

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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.

"We partnered with Broughton for extractables and leachables (E&L) testing on a Class IIa medical device. Their scientific team provided not just high-quality data, but clear interpretation aligned with MHRA expectations. The detail and integrity of their reporting gave us total confidence ahead of our UKCA submission."
“As we developed a nicotine vaporiser for medicinal use, we needed scientific guidance across both medical device and pharma requirements. Broughton helped us navigate this balancing aerosol testing, device design control, toxicology and CMC requirements for GMP compliance. Their laboratory testing and scientific consultancy was excellent and helped us meet timely project deadlines."
“Innovation is at the heart of everything we do but navigating the medical device regulatory landscape requires a partner you can rely on. Broughton supported us with expert scientific guidance, robust testing, and a clear regulatory strategy aligned with ISO 13485 and UKCA requirements. Their team integrated seamlessly with ours, helping us move faster while maintaining the highest standards of quality and compliance. When you're developing category-defining technology, you need a partner like Broughton in your corner."

hex-icon Solutions We Drive

Our analytical, development, and regulatory services support medical device companies, from innovative start-ups to established global manufacturers. Whether developing diagnostic equipment, ensuring regulatory compliance, or validating implantable devices, Broughton is your trusted partner for bringing safe and effective medical technologies to market. Product categories we support include:

Diagnostic equipment – Devices such as imaging systems and blood glucose monitors that support accurate detection and monitoring of medical conditions

Therapeutic devices – Technologies including infusion pumps and ventilators designed to treat and manage a wide range of health conditions

Surgical instruments and tools – Precision devices used across multiple surgical specialties, requiring rigorous quality and compliance standards

Implantable devices – Long-term use products such as pacemakers and orthopaedic implants, tested and validated to meet the highest safety standards

Wearable health technology – Connected devices for continuous monitoring, data capture, and therapeutic delivery, supporting patient outcomes

In vitro diagnostic (IVD) devices – Laboratory-based tools and kits for the analysis of biological samples outside the body

Your challenge, our drive – let’s deliver the solution together

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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.

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