Our services

Two divisions. One standard of work.

Fixed-fee, expert-led engagements delivered remotely or on-site across the UK. Jump to the division you need, or explore both.

MD QMS Assure — Compliance MD QMS Apex — Technology
MD QMS Assure · Compliance Consulting

Certification. Compliance. Confidence.

We build and align Quality Management Systems for MedTech, SaaS, FinTech and AI businesses across the UK — from gap analysis to full certification.

ISO 9001ISO 13485ISO 27001ISO 42001EU MDR / UK MDR / FDA
01

Gap Analysis

Understand your compliance position before committing to a full programme. Priced per standard.

What's included
  • Review of your current state against the target standard, clause by clause
  • Findings rated by risk, with a prioritised remediation roadmap
  • Fixed price per standard — no open-ended discovery
Deliverable: Gap report & remediation plan
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02

Full QMS Implementation

End-to-end QMS build for ISO 9001, ISO 27001, or ISO 13485 — from gap to certified.

What's included
  • End-to-end build to certification readiness for your chosen standard
  • Full document set — policies, procedures and records — written for your team
  • Support through Stage 1 and Stage 2 certification audits
Deliverable: A certification-ready QMS
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03

MDR / FDA Alignment

Align your existing QMS with EU MDR, UK MDR, or FDA requirements for market access.

What's included
  • Map your existing QMS against EU MDR, UK MDR or FDA QSR requirements
  • Close technical documentation and process gaps for market access
  • Built around your device classification and route to market
Deliverable: Market-access readiness pack
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04

Integrated Standard Bundles

Two certifications for significantly less than the cost of two separate implementations.

What's included
  • One integrated management system covering two standards (e.g. 27001 + 13485)
  • Shared controls and documentation instead of duplicated effort
  • Combined audit preparation across both standards
Deliverable: One integrated QMS, two certifications
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05

Internal Audit Support

Independent internal audit by a qualified external consultant — so your team stays confident and your certificate stays valid.

What's included
  • Independent internal audit by a qualified external consultant
  • Audit schedule, reports and nonconformity tracking
  • Keeps your certificate valid between surveillance audits
Deliverable: Completed internal audit programme
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06

Compliance Retainer

Ongoing compliance advisory on a monthly retainer — so your certification never drifts.

What's included
  • Monthly compliance advisory and document upkeep
  • Change management, audit prep and regulatory horizon-scanning
  • Your QMS adapts as the business and standards evolve
Deliverable: Ongoing compliance partnership
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Book a discovery call with Assure →
MD QMS Apex · Technology & Operations Consulting

Technology. Operations. At every level.

We help scale-ups and growth-stage businesses build the technology foundations, security posture, and operational processes to scale with confidence.

Azure SecurityCloud StrategyProcess DesignvCISOFractional CTO
01

Azure Technology Health Check

An independent assessment of your Azure environment — security, architecture, and governance — with a written technical report, management summary, and debrief presentation.

What's included
  • Independent review of your Azure environment: security, architecture, governance
  • Findings rated by risk against Microsoft Cloud Adoption & Well-Architected guidance
  • Written technical report, management summary, and a live debrief
Deliverable: Health-check report & debrief
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02

Process & Operations Design

Map, redesign, and document the core processes your business runs on. Priced by number of processes. SOPs your team can actually follow.

What's included
  • Map and redesign the core processes your business runs on
  • SOPs written for your team to follow — not shelfware
  • Priced by number of processes, so scope is clear upfront
Deliverable: Documented processes & SOPs
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03

Technology Roadmap

A clear, prioritised 12–24 month technology roadmap aligned to your business goals. Available standalone or bundled with the Azure Health Check.

What's included
  • Prioritised 12–24 month roadmap aligned to your business goals
  • Sequenced by impact and dependency, not vendor hype
  • Standalone, or bundled with the Azure Health Check
Deliverable: Prioritised technology roadmap
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04

Cloud Strategy & Migration Plan

A structured Azure cloud strategy and migration plan — architecture, security, governance, and phased migration — before you spend significant time or money.

What's included
  • Target Azure architecture: security, governance and landing zones
  • Phased migration plan with risk and cost weighed before you commit
  • Built to avoid expensive rework later
Deliverable: Cloud strategy & phased migration plan
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05

vCISO Advisory

Senior security leadership on a monthly retainer. Strategic cybersecurity oversight without the full-time cost of a CISO.

What's included
  • Senior security leadership on a monthly retainer
  • Strategic oversight: risk, policy, roadmap and board-level reporting
  • The CISO function without the full-time cost
Deliverable: Ongoing security leadership
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06

Fractional CTO

Experienced technology leadership embedded into your business part-time. Strategy, decisions, and direction without a full-time hire.

What's included
  • Experienced technology leadership embedded part-time
  • Strategy, architecture decisions and team direction
  • Scales up or down as your needs change
Deliverable: Ongoing technology leadership
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Book a discovery call with Apex →

Not sure which division you need?

Book a free 30-minute discovery call. We'll understand your situation and tell you exactly what an engagement would involve — no obligation.

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