Medical & Diagnostic Devices
Our experts are ready to help you find the perfect solution whether it’s hallmarking, analytical testing or valuations,
Independent elemental and materials analysis for regulated medical and diagnostic technologies
Medical and diagnostic devices increasingly rely on metal components, alloys and surface treatments for precision, durability and performance. Manufacturers operating in this highly regulated sector require accurate, independent analytical data to support product safety, compliance and technical documentation.
Birmingham Assay Office (BAO) provides independent elemental and materials analysis services through its UKAS accredited Analytical Testing Laboratory, supporting medical and diagnostic device manufacturers across development, production and post-market stages.
Your challenges...
Manufacturers of medical and diagnostic devices face increasing pressure to:
- Verify the elemental composition of metal components and alloys
- Control impurities and restricted substances
- Ensure suitability for patient or operator contact
- Support regulatory and compliance documentation
- Manage complex and precision-driven supply chains
- Reduce risk prior to market entry and during production
Independent analytical testing is essential in safety-critical environments.
How Birmingham Assay Office supports you...
Elemental & Materials Analysis
Our UKAS accredited laboratory provides independent analysis of:
- Metal components and assemblies
- Alloys used in diagnostic and medical devices
- Coatings and surface treatments
- Precision components requiring compositional verification
Delivering accurate data across major, minor and trace elements.
Prototyping, Pre-Market & Production Support
We support device development and manufacture through:
- Analytical testing at R&D and prototype stages
- Verification of material specifications prior to market release
- Batch and spot testing during scaled manufacture
- Independent confirmation of supplier material declarations
Helping identify material risks early and maintain consistency.
Materials Safety & Skin Contact Assessment
Our analytical services assist with:
- Assessment of materials intended for repeated or prolonged skin contact
- Identification of elements associated with irritation or sensitisation risk
- Support for low-irritation or hypoallergenic material strategies
Providing evidence to inform material selection and design decisions.
Regulatory & Compliance Support
We provide analytical data to support:
- Technical documentation and due diligence
- UK REACH and retained EU REACH requirements
- General Product Safety Regulations (GPSR)
- Independent evidence for audits, reviews and partner requirements
Delivering clear, defensible data suitable for regulatory scrutiny.
Get in Touch
If you develop or manufacture medical or diagnostic devices, Birmingham Assay Office’s Analytical Testing Laboratory can support you with independent elemental and materials analysis.
to discuss analytical testing services for medical and diagnostic devices.
Why choose Birmingham Assay Office?
- UKAS Accredited Analytical Laboratory – Independent, impartial testing
- Regulated Product Expertise – Experience supporting safety-critical devices
- Heritage of Assurance – Over 250 years protecting materials integrity
- Independent & Trusted – No involvement in device manufacture or sales
- Clear, Actionable Reporting – Suitable for technical and regulatory teams
Our independence and technical credibility make BAO a trusted analytical partner for medical and diagnostic devices.
“Birmingham Assay Office’s independent verification gave us complete confidence in our bullion transactions. Their authority and impartiality are invaluable in the investment metals market.“
Representative from
Global Jewellery Retailer
Contact us
Birmingham Assay office
0121 820 0773
Address
1 Moreton St, Birmingham, B1 3AX