Protect your R&D focus and field margins with expert Serviceability Architecture.
We conduct forensic design audits, write your ISO 13485 service manuals, and build your third-party repair networks. Protect your hardware margins and keep your R&D team focused on innovation.
Scaling a medical device without a service strategy is a regulatory and financial liability.
Your most expensive engineers are stuck acting as field support instead of developing your next-generation product.
Field repairs executed without ISO 13485 compliance create massive gaps in your QMS and audit trail.
High "No Fault Found" returns and inefficient repair loops erode your hardware margins during commercial scale-up.
A modular framework to protect your R&D team and scale your support.
Ensure your "Design Transfer" includes Serviceability. We perform forensic teardowns to identify maintenance risks and validate repair access before you freeze the design.
Stop relying on tribal R&D knowledge. We convert complex mechanical assemblies into validated, highly visual work instructions and compliance frameworks for your field engineers.
Scale without headcount. We build the "Turnkey" support package that allows you to hand over support to distributors or 3rd parties.
Turn "No Fault Found" returns into compliant Post-Market Surveillance evidence. We perform forensic physical root cause analysis to protect margins and provide closed-loop data for your ISO 14971 Risk Management files.
Founded by Dan Howes (ex-Bio-Rad, Thermo Fisher, RAF), Schema Technical brings the rigour of aerospace logistics to MedTech.
Having led the support architecture for complex systems like the Bio-Rad Genesis, we know exactly what happens when R&D prototypes hit the real world. A brilliant clinical device will fail commercially if the service infrastructure isn't built to match the engineering quality.
Embedded within the Cambridge, Norwich, and London MedTech hubs, we provide fractional service architecture to scaling device manufacturers nationwide and internationally.
We are not generalist management consultants. We are Service Architects. We operate across the entire hardware lifecycle: conducting forensic pre-freeze design audits to remove repair bottlenecks, building ISO 13485 compliant field infrastructures, and performing physical root cause analysis on post-market failures. We ensure your service operations are as robust as your clinical data, allowing your R&D engineers to focus on the next product while we protect your margins in the field.
We scope by mechanical complexity, not open-ended day rates. Fixed fees ensure ISO 13485 compliance is thoroughly funded without scope bleed.
*All engagements are scoped via an initial discovery call to ensure alignment with your current phase of commercialisation.
Find out if your device is ready for the field before your first customer complains.
Fill out the form to request a confidential discovery call with Dan.
Direct Email:
dan@schematechnical.co.uk