Philtronics Achieves ISO 13485:2016 Certification

We are proud to announce that we have successfully achieved ISO 13485:2016 certification for our Quality Management System. This internationally recognised standard demonstrates our ability to consistently provide medical device-related services that meet customer and regulatory requirements.

The scope of our certification covers:

• The manufacture of printed circuit boards, harnesses, and complete electronic assemblies to customer or Philtronics design, drawings, and/or specifications.
• The development and application of full turnkey testing solutions.

Issued on 16^th April 2026 by URS, this certification marks a significant milestone in our journey toward excellence in regulated manufacturing environments.

A Team Effort and a Major Milestone

Achieving ISO 13485 required dedicated effort from across the organisation. We would like to extend a heartfelt thank you to our entire team for their hard work and commitment over the past six months as we implemented the new standard. Their focus on robust processes, traceability, and quality controls has been instrumental in this success.

ISO 13485 is far more than a certificate on the wall — it reflects the systems, controls, and disciplined processes needed to operate reliably within the highly regulated medical device sector. For our customers, it provides greater confidence in quality, full traceability, and a manufacturing partner capable of supporting both development and full-scale production.

Building Momentum: A Year of Growth, Investment, and New Accreditations

This certification is yet another string to our bow. Over the past 12 months, we have pursued ambitious goals, achieved new accreditations, and made significant investments in our people and infrastructure. These efforts have collectively bolstered our technical capabilities and enhanced the service we offer to customers in medical, industrial, and high-reliability sectors.

Here’s what we’ve accomplished:

• ISO 13485:2016 — As detailed above, this provides a comprehensive quality management framework specifically tailored to medical device manufacturing, ensuring consistent product realisation, risk management, and regulatory compliance throughout the production lifecycle.
• UL 508A — This is the globally recognised safety standard for the construction of industrial control panels. It covers proper component selection, wiring methods, spacing, enclosure design, and short-circuit current ratings. UL 508A certification ensures our control panels meet stringent safety requirements, reducing risks of electrical shock, fire, or equipment failure in industrial applications.
• Cyber Essentials Plus — The UK Government-backed advanced cybersecurity certification, which includes independent technical verification of our controls. It protects against common cyber threats and demonstrates our commitment to safeguarding sensitive customer data, designs, and intellectual property — particularly important when handling medical device or industrial project files.
• Staff Development Initiatives — We have invested in our people through targeted training programmes, including Six Sigma (which drives data-driven process improvement, defect reduction, and operational efficiency) and SolidWorks CAD design training. These skills enhance our in-house design capabilities, improve collaboration on complex assemblies, reduce development time, and allow us to deliver higher-quality, more innovative solutions for our customers.

Together, these achievements have strengthened our end-to-end offering, from design support and precision manufacturing through to testing, certification, and secure delivery.

Why This Matters for Our Customers

As more organisations look to scale production or outsource specialist electronics manufacturing, having the right combination of quality, safety, security, and technical expertise is essential.

We are now even better positioned to support customers who require:

• Regulated medical device component and assembly production
• High-reliability electronics with full traceability
• Safe, compliant industrial control panels
• Secure handling of sensitive design data
• Efficient, continuously improving processes

Our recent progress reflects a clear strategic focus: delivering controlled, validated, and production-ready electronic solutions while maintaining the agility and personal service that our customers value.

Looking Ahead

This is an exciting time for Philtronics. The ISO 13485 certification, alongside our other recent accreditations and investments in talent, reinforces our position as a trusted manufacturing partner for demanding sectors.

We remain committed to continuous improvement and to supporting our customers as they bring innovative products to market.

If you would like to discuss how we can support your next project, please get in touch with our team.