In highly regulated industries-such as medical, aerospace, mobility, defence and product development is not just about performance and innovation. It’s about compliance, quality, and risk mitigation. When choosing an additive manufacturing (AM) partner, certifications are not a nice-to-have. They are a necessity.
At Prototal, we work with some of the most demanding sectors across Europe. To meet their needs, we’ve built a robust, certification-led foundation across our facilities, including:
- ISO 9001 & ISO 14001 – Quality and Environmental Management
- ISO 13485 – Medical Devices
- EN 9100:2018 – Aerospace
- IATF 16949:2016 – Transport / Mobility
- TISAX® and Cyber Essentials – Information Security in-line with industry standards
These certifications aren’t just stamps on a wall-they represent our commitment to operational excellence, traceability, and accountability. Here’s why that matters so much for regulated industries:
1. Compliance Isn’t Optional
When you’re producing components for a medical device, aircraft or automotive safety system, there is no room for error. Government bodies and industry regulators set strict requirements around product quality, documentation, testing, traceability and materials. A certified partner ensures that all processes-from order processing to final inspection-align with the required standards.
For example, ISO 13485 demonstrates that our systems support the safe manufacture of medical products and EN 9100 ensures we meet the traceability and documentation standards required for flight-critical parts within the aerospace sector. Operating within the confines of these standards ensures our customers are receiving conforming and quality assured components as standard.
2. Reduced Risk, Increased Trust
Regulated industries often face high consequences for failure: patient safety, public trust, or passenger lives may be on the line. By partnering with a certified AM provider, you minimise production risks and ensure your parts are manufactured under strict controls.
A certification like IATF 16949 shows that we’re equipped to manage complexity, meet tight tolerances and deliver consistent quality across automotive supply chains. It means we’ve proven our ability to prevent defects rather than react to them. That’s the kind of assurance your internal stakeholders, auditors, and customers expect.
3. Product Lifecycle
One of the key advantages of additive manufacturing is the ability to scale rapidly from early-stage design iterations to low and mid-volume production. But without a certified partner, each stage of the journey can introduce new risks and require new suppliers.
At Prototal, our certifications support the entire product lifecycle. From early design to full production using traceable processes, you get continuity and confidence all the way through. No need to revalidate suppliers, re-check documentation, or re-qualify parts when you’re ready to scale.
4. Better Data and Security Standards
In today’s digital-first world, data security is just as important as physical part quality. Sensitive CAD files, customer IP, and project information must be handled with care-especially in sectors like automotive and defence.
Our TISAX® and Cyber Essentials certifications ensure that our information security practices meet industry-specific requirements. Whether you’re transferring files, collaborating on revisions, or sharing confidential product data, you can trust that your information is secure throughout the AM process.
5. Sustainability and Responsibility
More and more regulated industries are being held accountable not just for what they produce, but how they produce it. Our ISO 14001 certification ensures that environmental impacts are monitored and minimised across all operations. Additive manufacturing already offers benefits in material efficiency and waste reduction and our certified practices help you align with global sustainability goals.
Final Thought: Certification Is More Than a Badge
At Prototal, we don’t view certification as a box to tick – it’s a reflection of the standards we live by. For our customers in regulated industries, it’s the foundation of every successful project. When the stakes are high, choose a partner who meets the highest standards.
Certified. Compliant. Capable. That’s Prototal.
