Certified Precision for Life-Critical Applications
At Prototal, we bridge the gap between advanced additive engineering and stringent clinical requirements. As a certified partner for the medical device and healthcare industries, we provide a validated pathway for the production of patient-specific implants, surgical instruments, and high-performance diagnostic components.
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.
The digital evolution of human mobility. Prototal is bridging the gap between clinical expertise and high-volume manufacturing for the O&P industry. We provide a specialized manufacturing framework that allows for the creation of fully customized, biocompatible orthotics and prosthetics without the limitations of traditional hand-lamination.
By leveraging serial 3D printing for runs up to 100,000 units, we enable clinics and device manufacturers to scale personalized designs—from high-strength lower-limb components to lightweight, breathable cranial helmets and spinal braces. Operating under ISO 13485 standards, we ensure that every device meets the highest benchmarks for medical safety, skin-contact certification, and durability, providing a localized European supply chain that moves at the speed of patient care.
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. 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.
