Medical electronics for controlled care

Medical electronics
for controlled care

Quality in standards & safety

Our experience of medical electronics spans a wide range of devices, from monitors and pumps to sexual health and rehabilitation products.

Our electronics team works closely with software and firmware experts to create safe, commercially successful solutions which include visually appealing product designs. We can provide a full development service with design, specification and procurement of systems hardware, including electronics and electro-mechanical components, as required alongside the software development.

Our robust design process ensures that products achieve the highest regulatory approvals. For medical devices, this includes CE marking and IEC 60601 for medical electrical equipment and systems – a key standard for manufacturers of medical devices which either detect or transfer energy to patients.

We are also ISO 13485 and ISO 9001 certified for design and model making in the UK, and for IDC China.

Software validation & regulatory control

We have many years’ experience creating software and firmware for devices and systems across a variety of industries, including the most highly regulated sectors of medical, defence and aerospace. For the medical sector, we are skilled at developing specialist validated software; delivering technology and functionality that is fully traceable to meet stringent regulatory standards.

Our software and electronics teams work closely to develop the best solutions for performance and cost. All our medical electronics and software is developed to meet appropriate regulatory requirements such as:

  • IEC 60601
  • EN ISO 13485
  • EN ISO 62304
  • EN ISO 14971
  • 21 CFR 820.30

As well as typical software programming languages such as C, C++, C#, Assembler etc, we have extensive experience programming FPGAs, CPLDs and ASICs, using hardware description languages (HDL) such as VHDL and Verlilog and verifying with test benches using ModelSim, with test vectors generated using Mathcad or Matlab.