Clinical small-series
manufacturing

Not sure yet how many units you'll need, or when? Tell us about your clinical programme, we'll get back to you within 48h.

What do we produce?

We produce complete finished medical devices, assembled, tested and documented to the same standard as industrial production. This includes:

Delivery systems

Complete catheter-based delivery systems including all sub-assemblies. We coordinate sub-contracted components (nitinol implants, precision shafts, injected parts) and integrate them into finished device assemblies.

Multi-lumen catheters

Complex catheter architectures assembled in-house using our extrusion, braiding, coating and micro-assembly capabilities. Balloon integration and hub attachment included.

Implant mechanical components

Surgical instrumentation & endoscopic accessories

Structural and mechanical parts for active implants; we handle mechanical assembly. Nitinol forming, silicone components, precision metal parts sourced through qualified partners.

MIS instrumentation assembled to final specifications. Component sourcing coordinated through our qualified supplier network.

Where required, we produce in our cleanroom (ISO class 8), with packaging and labelling to finished product standard. Every unit produced is traceable, documented and manufactured in accordance with a validated manufacturing instruction.

We build your pre-series, but that's not all we do.

That's the fundamental difference between Protomed's small-series capability and a prototyping shop that can produce a few extra units. When we set up a production run, we design it as if it were being handed over to a CDMO the next day: manufacturing instructions written to production standard (not bench notes), process parameters defined and validated (IQ/OQ/PQ where applicable), component suppliers formally qualified to ISO 13485 supplier management requirements, each unit tested against documented acceptance criteria, batch records maintained for every production run. When your clinical trial ends and you're ready to scale, the manufacturing transfer to a CDMO isn't a reinvention. The instructions, qualifications and validation data already exist. The CDMO takes your dossier and scales it, rather than starting over from your design. This approach also reduces clinical phase risk. If a manufacturing issue appears during clinical unit production, it appears now, not during a commercial launch industrial run.

We design the manufacturing chain you'll actually need.

The transfer Pathway

Our small-series manufacturing is explicitly designed as a bridge, not a destination. We position every production engagement within a clear transfer pathway:

We step in where we can make a difference. And when a client brings us a brief we think can be improved, we say so, because fixing a design in phase 2 always costs less than fixing it in phase 4.

ISO 13485 Certified Production : Every Unit Traceable

Every unit we produce is manufactured within our ISO 13485:2016-certified quality system. For clinical trial units specifically, this documentation package is structured to meet the requirements of your clinical investigation plan and to satisfy the expectations of your competent authority. Every lot is produced as if it will be audited.

Batch records maintained for every production run; component lot numbers, process parameters, inspection results.

Acceptance testing performed against documented criteria for every unit.

Non-conforming units identified, segregated, and dispositioned through our NCR process.

CAPA process for any production non-conformances; root cause, corrective action, verification.

Complete traceability from raw material to finished device.

Start your manufacturing project

Tell us about your device, your clinical programme, and your timeline. We will respond within 48 hours with an initial assessment of scope and feasibility.

FREQUENTLY ASKED QUESTIONS

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