Medical Additive Manufacturing: Certified Precision for Life-Critical Applications
At Prototal, we bridge the gap between advanced additive engineering and the stringent clinical requirements of modern healthcare. As a certified partner for the medical device and healthcare industries, we provide a validated pathway for production of components trusted by medical professionals across Europe. Our ISO 13485-certified additive manufacturing process ensures full traceability from concept to clinic.
By combining ISO 13485 compliance with our EOS-powered serial production, we deliver the biocompatibility, traceability, and mechanical certainty required for the most demanding medical applications.
ISO 9001:2016 | ISO 13485 | Cleanroom ISO 8
This isn't just a certificate; it is a promise of industrial-grade reliability.
By securing the ISO 13485 certification for 3D printing at our UK facility, we have bridged the gap between rapid digital innovation and the uncompromising safety standards of the medical industry. For our partners, it means they can finally move their most critical MedTech designs from concept to certified serial production under one roof, leveraging the agility of additive manufacturing with the peace of mind that comes from a fully validated medical quality management system.
— Martin Nottingham, Managing Director at Prototal UK
Your Strategic Manufacturing Architect
At Prototal, we don’t just view ourselves as a service provider; we are a strategic extension of your engineering and supply chain teams. In the fast-moving medical landscape, success is not just about the final part — it is about the engineering intelligence and partnership behind it.
We move beyond the “cost-per-part” conversation to focus on the total value of your product lifecycle. By joining your development process at the earliest stages, we help you navigate the complexities of material selection, biocompatibility, and certified production, ensuring your project moves from the idea to reality with zero friction.
Manufacturing Services for Medical Applications
Patient-Specific Performance. Industrialized.
One of the most transformative shifts in modern healthcare is the move toward personalisation. Our additive manufacturing technology makes it possible to produce patient specific devices at scale – components designed from individual CT or MRI data to match a single patient’s anatomy. From cutting guides and drilling templates to custom orthotics and patient matched devices, we deliver solutions that improve surgical accuracy and contribute directly to better patient outcomes.
Because 3D printing allows us to create complex geometries that are impossible to machine or mould conventionally, we can integrate features such as internal lattice structures to optimise weight, stiffness, and osseointegration in implant-adjacent parts. These engineered structures combine mechanical performance with biological compatibility – something traditional manufacturing methods simply cannot deliver economically at low volumes.
Reduced risk of stroke with the help of 3D printing
Qatna Medical closes the left atrial appendage with an implant to protect against strokes. The operation is successful thanks to the handle made from additively manufactured plastic components from our Austrian site 1zu1. These components mark a milestone for Industrial 3D Printing and the medical sector: sterilisable, production-ready, and regulatory-compliant components are now feasible.
Bring Your Design to Life
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Quote Your Next Project
Looking for high-quality industrial 3D printing solutions tailored to your needs? Our team is ready to provide a detailed quote for your project. Simply share your specifications, and we’ll deliver a clear, competitive estimate — no surprises, just precision and reliability.
Why choose us?
- 3D printing solutions for any scale and complexity
- Fast and accurate quoting process
- Local presence close to your business and business needs
FAQs
Do you have questions that needs answering? Here you can find the most common questions and answers.
We operate a decentralized network of certified centers of excellence to ensure supply chain resilience and local regulatory alignment – supporting the shift toward point of care manufacturing, where production sits closer to the medical professionals and clinical environments it serves. Each site is strategically specialized to handle different phases of the medical device lifecycle:
- Austria (1zu1scale): Our primary high-compliance hub, ISO 13485 certified for both Additive Manufacturing and Injection Molding. This facility features an ISO Class 8 cleanroom, providing the definitive environment for manufacturing and packaging clinical-grade components.
- United Kingdom: A specialized center for certified 3D Printing, holding ISO 13485 for additive processes. This site serves as a critical bridge for partners requiring high-complexity medical components within the UK regulatory framework.
- Malmö, Sweden: Our dedicated Injection Molding center of excellence, ISO 13485 certified to support high-volume serial production of medical consumables and device housings.
By distributing these capabilities across Europe and the UK, Prototal provides a unique “dual-sourcing” advantage. Whether you are validating a new patient-specific instrument through 3D printing in Austria or scaling a diagnostic housing to mass production in Malmö, your project remains under a consistent, validated Medical Quality Management System.
