Markets
From co-engineering to series production
Tumag supports companies in the medical, pharmaceutical and personal care sectors with high-quality precision parts, tools and injection moulds.
We work in accordance with ISO 9001, which means our processes are structured, documented and continuously monitored. For customers in regulated sectors, this provides a solid foundation to build on.
Typical points of attention in these industries are:
- strict quality and validation requirements
- material suitability and biocompatibility
- full traceability and documentation
Because we carry out all machining activities in-house, we combine technical flexibility with strict quality control.
What we do for your sector
Products in these sectors come into direct contact with people or sensitive contents. This requires precise dimensional accuracy, suitable materials and full documentation of the production process. Because design, machining and measurement all take place under one roof with us, we avoid unnecessary steps and maintain control over every stage of the process. Where the application requires it, we provide a measurement report for medical parts that records the measured tolerances in a traceable way.
Thinking along from design through to quality control and delivery
We get involved as early as the design phase, ensuring that a product is actually manufacturable under the applicable regulations. This includes material selection, functional tolerances and combining multiple functions into a single component — always in close coordination with the customer.
Applications in pharmaceutical packaging, medical devices and personal care
We work on components for controlled dosing, leak-tight systems, repeated mechanical use and aesthetic finishes for personal care. In addition, we produce cutting tools and precision tools for blister packaging and other packaging processes, where wear resistance and dimensional accuracy are decisive for the final result.
Material expertise for medical and pharmaceutical applications
Choosing the right material starts with the application: contact duration, body location, sterilisation method and required certifications together determine which material is suitable. Surface-contact applications, for example, are subject to less stringent requirements than long-term implantable applications, where only the most extensively tested materials are accepted. The biocompatibility of a material is assessed according to the ISO 10993 series of standards, which evaluates the biological safety of medical devices in relation to the specific application.
Tumag works with a wide range of plastics and metals, tailored to the requirements of the sector. For plastics, these include PC, PP, PE, PEEK and certified TPEs. For precision mechanical applications and tooling, we also use metals, including titanium and medical-grade stainless steel (316L/316LVM). Both metal types are used for their biocompatibility and mechanical properties, each with its own characteristics in terms of corrosion resistance, strength and cost.
| Material | Type | Typical application | Relevant standard / property |
| PEEK | Plastic | Structural implants, precision mechanics | ISO 10993, ASTM F2026 |
| PC (polycarbonate) | Plastic | Housings, diagnostic components | Medical grade, ISO 10993 |
| PP / PE | Plastic | Packaging, dosing systems | Medical grade, FDA-compliant |
| TPE | Plastic | Flexible components, seals | Medical or cosmetic certification |
| Stainless steel 316L / 316LVM | Metal | Surgical instruments, tooling, temporary implants | High corrosion resistance, proven biocompatibility |
| Titanium | Metal | Long-term implants, load-bearing structures | Excellent osseointegration, low ion leakage |
Sources: ISO 10993 (biological evaluation of medical devices), FDA guidance on biocompatibility, Criterion Precision – Biocompatible Materials for Machined Implants
Validation and quality assurance
A technically correct product is the starting point, not the end point. We support test and validation processes, trial productions and the definition of stable process parameters. Quality control takes place in a climate-controlled measuring room, with measurement reports and full traceability for each production series.
For parts that must remain permanently traceable, we apply serial numbers, Data Matrix codes and UDI markings directly into the material using metal engraving.
Frequently asked questions (FAQ)
What is biocompatibility and which materials are suitable?
Biocompatible materials can safely come into contact with the human body without causing harmful effects. Their suitability depends on contact duration, application and certifications such as ISO 10993. An overview of the materials processed by Tumag, including standards and applications, can be found in the material table above.
How does Tumag guarantee consistent quality?
Through process control, validation and documentation — with measurement reports, traceability of materials and processes, and internal measurements in a climate-controlled environment. Preventive maintenance and continuous follow-up ensure stable results over the long term.
What is the difference between a medical device and pharmaceutical packaging in terms of production requirements?
For medical devices, the focus is on functional safety, mechanical reliability and traceability of the component itself — often under the MDR Regulation (EU 2017/745). Pharmaceutical packaging is subject to other guidelines, where the interaction between the packaging material and its contents (extractables & leachables) plays a central role. Both routes require documented material choices and validation, but the assessment frameworks and responsibilities differ.
Which sterilisation methods are compatible with the materials processed by Tumag?
This strongly depends on the chosen material. PEEK withstands steam sterilisation (autoclave), EtO gas and gamma irradiation. PP and PE are generally gamma-resistant, but less suitable for high autoclave temperatures. PC is more sensitive to repeated steam sterilisation. During the design phase, we take the intended sterilisation method into account, so that the material and geometry are aligned with it from the outset.
What does traceability mean in practical terms in your production process?
Traceability means that, for every production batch, we can demonstrate which material was used, which process parameters applied, when measurements were carried out and what the results were. This includes material documentation from the supplier, internal measurement reports and production records for each batch. This means that, in the event of a deviation or audit, the full production history can always be traced back.
