Plug us in where it counts.
From a first quality system to a high-stakes inspection, we work alongside your team and do the work with you — not just hand over a report.
QMS Design & Implementation
A quality management system your team will actually use — sized for your product and stage, not a 400-page binder nobody opens. We design the structure, write the core processes, and get it live.
- Quality manual & process architectureRight-sized to ISO 13485 / ISO 9001
- SOPs, work instructions & templatesPractical documents people follow
- Document & record controlLean structure, ready for eQMS if needed
- CAPA, change & deviation processesThat close out instead of piling up
Audits & Inspection Readiness
Walk into your next audit calm. We run internal and gap audits, fix what carries real risk, and prepare your people for notified body, FDA and customer inspections — including hosting support on the day.
- Internal & gap auditsHonest findings, prioritised by risk
- Notified body & FDA prepMock audits and front/back-room coaching
- Supplier auditsQualify and monitor critical suppliers
- CAPA & finding remediationResponses that actually hold up
Regulatory & Compliance
Keep products on the market and projects moving. We build technical documentation, run risk management to ISO 14971, and help you navigate MDR and FDA pathways without losing momentum.
- Technical documentation & design history filesStructured, defensible, complete
- Risk management — ISO 14971Risk files that connect to real evidence
- EU MDR & FDA pathway supportClassification, routes, submissions
- Post-market surveillance & vigilancePMS plans, PMCF, complaint handling
Training & Coaching
Quality lasts when it lives in the team. We train and coach your people so the system runs without us — practical sessions tied to your own processes, not generic slideware.
- Standard & process trainingISO 13485, 14971, MDR essentials
- Internal auditor developmentBuild your own audit capability
- Leadership & quality-culture coachingBuy-in from the top down
- Onboarding playbooksNew hires productive faster
Work with us the way that fits.
Defined scope
A clear deliverable with a fixed start and finish — an implementation, a remediation, an audit prep. Scoped, priced, done.
Ongoing support
A trusted quality partner on call — a set number of days each month for reviews, coaching and the questions that come up.
Embedded quality
Hands-on cover for a quality role during growth, transition or a gap — embedded with your team for the period you need.
Not sure where to begin?
Tell us the problem in plain words. We'll tell you honestly whether — and how — we can help.
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