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Cobalt is pleased to announce a significantly upgraded Quality Management System (QMS), designed to align with stringent, high-end Medical Device standards (ISO 13485).

ISO 13485 is an internationally recognised standard for the design, development and manufacture of medical devices. It represents one of the highest quality standards a company can achieve.

This enhanced process is centred around user needs (usability engineering), risk mitigation (ISO 14971), evidence-based decision-making and traceability. This benefits all our clients by providing an accountable framework for delivering high-quality outputs, every time. Although designed for medical device projects, this system can also be directly applied for the development of complex or high-risk products, even where regulatory approval isn’t required. Additionally, for smaller projects we can tailor a subset of these processes to meet the project needs and client’s budget.

Once certified, the benefit of partnering with Cobalt for projects in highly regulated spaces, such as aerospace or defence and especially medical devices will be significant:

  • This QMS ensures our methodology and controls are optimised to meet stringent requirements for complex device design, development, and maintenance. This includes ongoing internal and external auditing to ensure we continue to achieve high-quality results for our clients.
  • We’ll take care of the development process documentation, leaving time for clients to focus their efforts on other critical elements such as commercialisation, regulatory strategy or developing their own QMS (if not yet in place; we can assist you).
  • Our D&D documentation (design history) can also be directly used within the client’s own regulatory approval process, streamlining the submission and final commercialisation process.
  • A user-centred approach forms a key part of this standard. Lucky for us, our design methodology already revolves heavily around user-focused decision-making – so it will only mean our projects will be safer, more effective, and easier to use for users.

The creation of this upgraded QMS is a stepping stone towards further strengthening our capabilities in advanced industries – helping us validate our commitment to quality and further contribute to meaningful medical, defence or advanced technology innovation.

Ask us how this new QMS will benefit your next project

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