Quality systems your team can rely on, and auditors can trust

A robust quality management system is not a regulatory checkbox. It is the backbone of sustainable product quality. We design, run, and optimise quality systems that fit how your team actually works, so compliance holds up under inspection and in daily practice.

What we offer Get in touch

What we offer

How we help your team

Practical, hands-on support, shaped around your products, your team, and the outcomes you need.

QMS design and optimisation
We build and refine quality management systems aligned to ISO 13485, ISO 9001, ISO 14971, FDA 21 CFR Part 820, and EU MDR and IVDR. Each system is shaped around your products, your risks, and the way your team works.
CAPA and deviation management
We accelerate root-cause analysis and clear deviation backlogs without cutting corners. The aim is not a closed record, but a change that prevents the issue from returning.
Audits and inspection readiness
We run internal and supplier audits, and prepare your team to face regulatory inspection with confidence. You get a clear view of the gaps and a practical plan to close them.
GxP and GMP compliance assessments
We assess your operations against GxP and GMP expectations across the product lifecycle. Findings arrive prioritised and workable, not as a list of problems.
Post-market surveillance and vigilance
We set up and run post-market surveillance, complaint handling, and vigilance reporting. Field signals feed back into the product, not just the file.
Electronic QMS and data integrity
We help you move to an electronic QMS with real-time monitoring and automated compliance tracking, with data integrity designed in. Less manual chasing means more time for the work that matters.

How we work

Three ways to bring us in

Quality and Compliance can be delivered through any of our three models. You choose where ownership of the work sits.

01
Project staffing
Our specialists, embedded in your team.
QA managers, CAPA and deviation specialists, and auditors, embedded in your quality team.
You direct the work, we bring the expertise
02
Managed services
We run it against your KPIs.
Managed services for QMS operations: document control, CAPA, complaints, and supplier quality, run against your KPIs.
You set the objectives, we run the day to day
03
Advisory and delivery
We define it, then build it with you.
Advisory and delivery for QMS remediation and inspection readiness, from gap assessment to a system that holds.
Shared, from roadmap through implementation