Surgical, Wearable & Implantable Technologies

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Independent elemental and materials analysis for safety-critical medical technologies

Surgical instruments, wearable medical technologies and implantable components rely on precisely controlled materials, surface finishes and metal compositions to ensure safety, performance and durability. Organisations developing and manufacturing these technologies operate within highly regulated environments where independent analytical evidence is essential.

Birmingham Assay Office (BAO) provides independent elemental and materials analysis services through its UKAS accredited Analytical Testing Laboratory, supporting manufacturers of surgical tools, wearable medical devices and implantable technologies across development, production and post-market stages.

Your challenges...

Manufacturers and developers in this sector face increasing pressure to:

  • Verify the elemental composition of metals, alloys and components
  • Control trace impurities that may affect performance or biocompatibility
  • Ensure suitability for repeated skin contact or implantation
  • Support regulatory and technical documentation
  • Manage precision manufacturing and complex supply chains
  • Reduce risk prior to clinical use and market placement

Independent analytical testing is critical where patient safety is paramount.

How Birmingham Assay Office supports you...

Elemental & Materials Analysis

Our UKAS accredited laboratory provides independent analysis of:

  • Surgical instruments and reusable tools
  • Wearable medical device components
  • Non-active implantable components and sub-assemblies
  • Alloys, coatings and surface treatments

Delivering accurate data across major, minor and trace elements.

Prototyping, Pre-Market & Production Support

We support product development and manufacture through:

  • Analytical testing at R&D and prototype stages
  • Verification of material specifications prior to clinical or market use
  • Batch and spot testing during routine manufacture
  • Independent confirmation of supplier material declarations

Helping identify material risks early and maintain consistency.

Materials Safety, Skin Contact & Implant Considerations

Our analytical services assist with:

  • Assessment of materials intended for prolonged or repeated skin contact
  • Identification of elements associated with irritation or sensitisation risk
  • Support for material selection strategies focused on safety and performance

Providing evidence to inform design decisions and risk assessments.

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 surgical instruments, wearable medical devices or implantable technologies, Birmingham Assay Office’s Analytical Testing Laboratory can support you with independent elemental and materials analysis.

to discuss analytical testing services for surgical, wearable and implantable technologies.

Why choose Birmingham Assay Office?

  • UKAS Accredited Analytical Laboratory – Independent, impartial testing
  • Safety-Critical Expertise – Experience supporting surgical, wearable and implantable technologies
  • Heritage of Assurance – Over 250 years protecting materials integrity
  • Independent & Trusted – No involvement in device manufacture or sales
  • Clear, Actionable Reporting – Suitable for technical, regulatory and quality teams

Our independence and technical credibility make BAO a trusted analytical partner for advanced medical technologies.

  • Case Study

    Materials Analysis for a Wearable Medical Device

    Click through to find out more

  • The Challenge

    A manufacturer developing a wearable medical device incorporating metal components required independent elemental analysis to assess material safety and support technical documentation.

  • Our Approach

    1 - Conducted UKAS accredited elemental and coating analysis

    2 - Assessed materials for restricted or sensitising elements

    3 - Issued clear analytical reports suitable for regulatory and partner review

  • The Results

    1 - Increased confidence in material selection

    2 - Reduced risk prior to market launch

    3 - Strengthened technical documentation and due diligence

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.

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Birmingham Assay office

0121 820 0773

Address

1 Moreton St, Birmingham, B1 3AX