Healthtech

Advancing medical systems with complex electronics and software

Medical systems impose a unique combination of safety, regulatory, and technical demands. For the electronics and software involved it’s not just about developing a working system, it’s also about making them safe, reliable, traceable, and regulatory approved, in environments where failure is unacceptable.


What we do best

Safety-Critical Design and Regulatory Compliance

Whether for use in Space, Defence, or Medical Systems, Plextek is highly skilled in developing the electronic and software systems for use in safety critical situations. In the HealthTech sector failures can have life-or-death consequences, so systems must be highly reliable, fault-tolerant, and designed with redundancy, and these requirements are often reflected in stringent verification and validation protocols

Our Quality System is compliant to ISO 13485, and where appropriate our projects will comply with, amongst others, ISO 14971 for risk management, IEC 60601 for electronics, and IEC 62304 for medical software.

Regulatory compliance also extends to cybersecurity, and for connected devices HIPAA and GDPR compliance is critical.


Complex Integration

Complex Integration

The electronics and software that Plextek develop will often form a vital part of complex medical systems, and as such integration within the wider system architecture is an essential part of our offering to clients.

Software development is often complicated by the requirement for complex signal processing, stringent data integrity, along with real-time operation.


Reliability Under Constraints

Plextek prides itself on the development of low size, weight, and power devices in all the markets in which it operates. These constraints are even more prevalent in the medical sector. The electronics within medical devices also often have to contend with additional constraints such as sterilisation, long-term use, and harsh medical environments.


Long Product Lifecycles

Whilst medical systems can take many years to launch, they also tend to remain in use for decades. Therefore, designs must play close attention to maintenance, updates, and component obsolescence management.


Our Process

Requirements analysis & risk assessment
Concept development, system architecture & design
Development & verification
Testing & validation
Regulatory submission support

From concept to compliance, we ensure both innovation and regulatory success

Why choose Plextek for your project?

We Deliver

We’ve built our reputation on delivering systems that work when lives depend on them. Our ISO 13485 certification reflects the rigorous quality processes we’ve refined across aerospace, defence, and medical projects.

We can handle everything from the first circuit sketch, whether that’s designing custom technology, writing software, or navigating compliance. This means fewer handoffs and better integration. We work closely with clients throughout the process, adapting to how you prefer to operate, and we stick around after launch.

Standards & Certifications
  • Plextek holds ISO 13485 certification for Medical Device Quality Management Systems.

We design and develop to the highest industry standards including ISO 14971 for risk management, IEC 60601 for electronics, IEC 62304 for medical software, and IEC 62366 for usability engineering. Our connected devices comply with HIPAA and GDPR requirements for data protection and privacy.

Quality Assurance & Accreditations

Application examples:

  • Diagnostic Instruments
  • Imaging Systems
  • Digital Health
  • Patient Monitoring Systems
  • Connected Devices
  • Wearables
Talk to our experts

Get Started

Ready to discuss your HealthTech project? Our experienced team is here to help you navigate the complex landscape of medical device development.