Medtech and healthcare demand the highest level of precision, quality and regulatory compliance. Products and solutions must meet strict regulatory requirements while remaining safe and stable over time. Traceability and control across the whole chain are central to this industry.
Documentation starts at the first sketch. Drawings, revision history and material choices that hold up to scrutiny across the product's whole life cycle.
Project & engineeringEvery part carries material certificates and measurement records from raw material to delivery. Welding follows ISO 3834-2 and is carried out by qualified welders.
Production & manufacturingEvery movement is documented, from supplier to recipient. Batches are kept separate and stored traceably through the chain.
Logistics & material flowsMeasurement records per part, linked to batch and material certificate. Verification is documented and can be reviewed after the fact.
Quality assuranceOur certificates are audited by Qvalify and can be verified via their combined certificate.
Quality management system audited by Qvalify. Structured processes, documentation and improvement work — the foundation for medtech supplier agreements.
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Environmental management system across production. Structured work on resources, emissions and chemical handling.
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Occupational health and safety management system audited by Qvalify. A structured approach to safety, the working environment and risk prevention across production.
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Verified by an independent party. Relevant to medtech OEMs' sustainability requirements.
We manufacture mechanical components for medtech and healthcare — where traceability and documentation are requirements. Get in touch — we'd be happy to talk.
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