Medical Devices

GLC supported the development of a miniature surgical gamma probe used in oncological procedures. The device formed part of a regulated medical product portfolio owned by a major pharmaceutical organisation, with software classified as MDR Class II with IEC 62304 Class B software.

At the point of engagement, the programme was operating under significant regulatory and delivery pressure. Fewer than 90 days remained before MDR resubmission, and the outstanding list of software non-compliances was widely considered unmanageable with the existing resources and pace of development.

The situation required not only technical intervention but a clear understanding of client priorities, regulatory expectations and immovable deadlines.

At engagement, the programme was under intense regulatory and delivery pressure, with fewer than 90 days before MDR resubmission and a backlog of software non-compliances deemed unmanageable with existing resources.

Success required not just technical expertise but a clear grasp of client priorities, regulatory expectations, and fixed deadlines.

We worked closely with the client’s engineering, quality, and product teams to stabilise the programme and regain control of both delivery and regulatory risk.

From the outset, we aligned on what genuinely mattered for the upcoming MDR submission and committed to a focused, outcome-driven recovery plan.

• Rapid assessment of the compliance landscape, prioritising actions with the highest regulatory and technical impact

• Targeted refactoring of a safety-critical embedded codebase to address key compliance gaps

• Clear technical leadership on safety-critical embedded architecture and design decisions

• Direct integration of regulatory requirements into day-to-day engineering activities, rather than treating compliance as a parallel documentation exercise

• Establishment of practical verification and automated testing approaches appropriate to the device classification, including a fully bespoke implementation of unit tests, while carefully maintaining codebase stability to support imminent releases

• Support for software risk and cybersecurity analysis aligned with medical device regulatory expectations

Despite the challenging starting position, the programme progressed to a controlled and defensible MDR resubmission within the available timeframe.

The resubmission resulted in a clean outcome for software compliance against IEC 62304, an exceptional result given the initial volume of non-compliances, the compressed timeline, and the maturity of the legacy codebase.

The software platform was stabilised, regulatory risk within the software domain was eliminated and the client regained confidence in both the technical solution and the delivery plan.

By maintaining a relentless focus on agreed priorities and what was achievable within the deadline, GLC helped transform a situation widely viewed as impossible into a successful, on-time outcome.