Services / MD QMS Assure

MD QMS Assure · Quality & regulatory

Compliance retainer & internal audit

Certification is the start, not the finish. We keep your QMS current, run independent internal audits and prepare you for surveillance audits, on a fixed monthly fee.

Why it matters

Internal audits must be independent of the work being audited, which is hard to achieve in a small team.

Regulations and standards keep moving. A retainer means someone is tracking what changes for your products and updating the system before an auditor finds the gap.

Who it’s for

  • Certified manufacturers without a full-time QA/RA team
  • Companies between surveillance audits that want an independent view

What’s included

  • Annual internal audit programme by a qualified external auditor
  • Audit reports and nonconformity tracking
  • Surveillance and recertification audit preparation
  • Document upkeep and change management
  • Quarterly regulatory horizon briefing tailored to your products

Deliverable

Ongoing compliance partnership.

Everything we write is yours to own and maintain. We stay available for auditor or reviewer questions on anything we produced.

How it works

01

Discover

A free 30-minute call to understand your product, markets and deadline.

02

Define scope

A fixed-fee proposal within two working days: deliverables, exclusions, timeline and price.

03

Build evidence

We do the work with your team, not around it. Everything is written for you to own.

04

Support delivery

We stay with you through audits, submissions and reviewer questions on anything we wrote.

Questions we’re often asked

Is there a minimum term?

Retainers run for a minimum of three months, billed monthly in advance, so the first audit cycle can be completed properly.

Talk to us about Retainer & audit

Book a free 30-minute discovery call. We’ll understand your product and deadline, and tell you exactly what an engagement would involve and cost. No obligation.

Regulatory radar

Get the changes that matter, explained.

FDA, MDR, EUDAMED, the AI Act and medical-device cybersecurity: what changed and what it means for your product. Low volume; unsubscribe any time.