Healthtech

For medical device development specifically, our engineers work to the same rigorous standards applied in aerospace and defence, carrying that culture of zero-failure design into 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.

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.

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.

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.