About Us
ISO 13485
eg technology is ISO 13485 accredited, demonstrating our commitment to quality, traceability and regulatory compliance throughout the development of medical devices.
We apply robust quality management processes across our projects, helping clients progress efficiently from concept through to manufacture while maintaining the documentation, design controls and risk management activities required within regulated environments.
Supporting Successful Medical Device Development
Developing a medical device requires more than technical innovation. Regulatory requirements demand evidence that products have been developed through controlled processes, with appropriate consideration of safety, performance, usability and risk.
Our ISO 13485-accredited quality management system supports all stages of product development, including:
- Product requirements definition
- Design and development planning
- Risk management
- Design reviews and traceability
- Verification and validation activities
- Design transfer to manufacture
By embedding these activities throughout the development process, we help clients reduce technical and regulatory risk while maintaining project momentum.
A Trusted Development Partner
Whether supporting start-ups bringing a first product to market or established medical technology companies expanding existing portfolios, we work as an extension of our clients’ teams, providing specialist engineering expertise and additional development capacity where needed.
eg technology were one of the first Cambridge consultancies to have gained ISO 13485 accreditation, in July 2010. As such, our multidisciplinary team has extensive experience developing products across a broad range of medical and diagnostic applications within an ISO 13485 framework. We help organisations navigate complex technical challenges while maintaining robust development practices.
Why work with an ISO 13485-accredited Development Partner?
Working with an ISO 13485-accredited product development partner can help organisations to:
- Improve traceability throughout development
- Strengthen design control processes
- Support regulatory submissions and compliance activities
- Reduce development risk
- Facilitate a smoother transfer to manufacture
- Maintain confidence in product quality and documentation
Medical Device and IVD Expertise
Our team supports the development of innovative medical devices and diagnostic products, combining expertise in industrial design, mechanical, electronics, software and systems engineering and human factors with a structured approach to quality and compliance.
From feasibility studies and technology development through to verification, validation and manufacturing support, we help clients deliver products that are safe, effective and aligned with regulatory pathways.
Looking for support with your next medical device or IVD development programme? Contact our team to discuss your requirements.
ISO 13485 Requirements
Product and user safety are critical for medical device compliance. ISO 13485 specifies requirements for a quality management system which can demonstrate a company’s ability to design and manufacture medical devices & IVDs that consistently meet applicable regulatory requirements and customer specifications.
Any medical device or IVD placed on the market must comply with the relevant classifications:
- USA: compliance and approval to FDA regulations for Medical devices:21CFR.
- Europe: MDR and IVDR requirements
