Materials expertise for medical technology
For manufacturers, operators and approval managers in medical technology:
Material consulting, failure analyses and fitness-for-use assessments – standard-compliant, traceable, MDR-compliant.
CHALLENGE
In medical technology, material failure has immediate consequences – regulatory and clinical.
- An implant or instrument fails in service – cause and responsibility are unclear.
- Corrosion, fatigue fracture or unexpected embrittlement jeopardize product safety and market approval.
- Is a component still safe to use after an incident – or must it be recalled?
- What caused the failure – and how do we prevent it from recurring?
Component failure, recall or ongoing approval procedure?
SERVICES
Our services for medical technology
Forensic failure analysis
Systematic root cause investigation in component failure – implants, instruments, housings, fasteners. Fractography, metallography, EDX analysis. Standard-based documentation according to VDI 3822 for authorities, insurers and manufacturers.
Fitness-For-Service analyses
Objective assessment of the fitness-for-service of components and systems – including after incidents or changed operating conditions. Estimation of safe remaining service lives as a basis for continued-operation or recall decisions.
Material & welding consulting
Consulting on material selection for implants, instruments and medical devices, taking into account biocompatibility, corrosion resistance and manufacturing requirements. Support with material specifications for approval procedures.
REGULATORY FRAMEWORK
Standards expertiseREGULATION & STANDARDS
Medical technology requires more than technical expertise – it requires regulatory understanding.
Our analyses and material assessments provide standard-compliant evidence for post-market surveillance, vigilance reports and technical documentation in accordance with MDR requirements.
PROJECT REFERENCES (ANONYMIZED)
From practice – what we have achieved for manufacturers and operators
Electrochemical analysis and SEM/EDX examination after premature implant failure. Crevice corrosion identified as the primary mechanism.
→ Standard-compliant expert report prepared for vigilance procedure
Complete material characterization and biocompatibility evidence in accordance with ISO 10993 for an active implant in the MDR approval procedure.
→ Technical documentation successfully submitted to notified body
Fractographic analysis after intraoperative fracture of an instrument. Fatigue failure due to a material defect from manufacturing demonstrated.
→ Liability clarification against manufacturer successfully concluded
COLLABORATION
How a collaboration works
Request
A brief description of your concern – component, incident or question. By form, email or phone.
Initial consultation
Within 24 hours we get back to you with an initial assessment and agreement on the scope of the investigation.
Analysis
Testing in the laboratory or on site. Complete process chain with seamless documentation of all investigation steps.
Report & consulting
Standard-based final report with recommendations for action – suitable for authorities, insurers and internal QM processes.
Acute failure case or ongoing revision?
WHY TECHNICAL CENTER
What manufacturers and operators value about our work
We know the requirements of MDR, ISO 13485 and notified bodies – and deliver documentation that holds up in approval procedures.
All testing and analysis steps are fully documented – as a basis for internal QM systems and external audits.
Our reports are structured according to VDI 3822 and designed for use in vigilance procedures, liability disputes and official proceedings.
No ties to material suppliers or device manufacturers – we assess objectively and exclusively in the interest of the client.
TYPICAL OCCASIONS
When manufacturers, operators and lawyers contact us
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After a component failure that requires a vigilance report or a notification to the authorities
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During an ongoing MDR approval procedure with open material evidence or documentation gaps
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In liability disputes between manufacturer, operator and patient
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When a decision must be made whether a product can be recalled or remain in use
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In the development of new implants or instruments with demanding material requirements
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As external expertise for post-market surveillance reports and clinical evaluations
FREQUENTLY ASKED QUESTIONS
