From a single audit to your whole quality system.

Gap, internal and supplier audits against the standard that applies to you. I find the findings before your notified body or inspector does, with a prioritised action list in plain language you can work through.

• A clear picture of where you stand
• Findings prioritised by risk, not by volume
• Carried out on site or remotely

Set up your first quality system before certification. I build a lean, compliant QMS that fits how your team actually works (not a 140-procedure template you'll never use).

• A documented QMS aligned to ISO 13485, EU MDR or GDP
• Procedures written as clear, step-by-step instructions
• Ready to put in front of a notified body

Your QMS has grown into something that slows down every release. I prune it back to what's clear, fast and fully compliant, and close the gaps that crept in along the way.

• Fewer, sharper procedures your team actually follows
• Redundant records and processes removed
• Faster turnaround without losing compliance

Procedures, work instructions and templates written as clear, step-by-step text. Documentation your team follows easily and auditors approve without questions, not to fill a binder.

• Procedures and work instructions in plain language
• Aligned to the standard and to your day-to-day practice
• Templates and forms that make the work lighter

Senior quality capacity when you need it: to cover leave, support a ramp-up, or hit a deadline you can't miss. Hands-on from day one, without a long onboarding.

• Experienced support without a permanent hire
• Productive straight away, not on the org chart
• Flexible by the day, week or project