Quality systems that
work in the real world.

Not every medical device company needs a full internal regulatory affairs and quality assurance department. Many companies — particularly those scaling from startup through first submission — need senior RA/QA capability without the overhead of hiring it.

We operate as an extension of your team: ongoing regulatory maintenance, document control, change management, CAPA oversight, supplier quality, and regulatory intelligence. We attend your design reviews. We respond to regulatory queries. We keep your QMS current as your product and your market evolve.

Structured as a retainer engagement, with defined scope and a named point of contact who knows your product.

We design and implement quality management systems calibrated to your organisation's size, product complexity, and target markets. From gap analysis against ISO 13485:2016 through to a full procedure library — we get you audit-ready without over-engineering the system.

A QMS that's too light fails your notified body. One that's too heavy fails your team. We build systems that people actually follow.

Standard operating procedures written by people who understand medical device development — not generic templates adapted from another industry. We write SOPs for design control, risk management, complaints handling, CAPA, supplier management, and change control in language your team will actually follow.

Independent internal audit against ISO 13485 and applicable regulations, with a structured non-conformance and CAPA report. We identify systemic issues before your notified body or CDSCO does — and we tell you exactly what needs fixing, not just that something is wrong.

Focused training for engineering, clinical, and quality teams on IEC 60601-1, ISO 14971, IEC 62304, IEC 62366, CDSCO MDR 2017, and EU MDR. Delivered as workshops or structured onboarding for new team members entering a regulated environment.