A Single Platform for Global Compliance

We provide structured, audit-ready consulting services spanning gap analysis, internal audits, mock audits, turnkey QMS implementation, digital QMS deployments and ad-hoc support. All services map directly to ISO 13485, ISO 14971, MDR, FDA QSR and global regulatory expectations.

Service Breakdown

QMS Gap Analysis (Bronze / Silver / Gold)

Bronze (Document Review Only)

  • Remote review of your existing QMS documentation against ISO 13485 clause map
  • Findings report
  • Prioritised remediation plan

Silver (Process + Records Sampling)

  • Includes Bronze
  • Interviews + record sampling
  • Maturity scoring
  • Remediation backlog with owner + due dates

Gold (Deep Dive)

  • Includes Silver
  • On-site process walk-throughs
  • Supplier and production floor sampling
  • Management briefing with KPI model

Deliverables:
Gap report by clause, risk-based remediation plan, remediation Gantt timeline, management briefing deck.

Design Controls Remediation (Clause 7.3)

Includes:

DHF structure, missing record reconstruction plan, design review and change control hard-locks.

Outsourced Internal Audit

Includes:

  • Annual audit program design
  • Audit execution per process family
  • Reports
  • Follow-up verification of effectiveness
  • Board-ready dashboard

Ad-Hoc Consultancy (Blocks of Hours)

5 / 10 / 25 / 50 hour blocks for:

  • CAPA coaching
  • Supplier qualification
  • DHF / DHR clean-ups
  • PMS signal analysis
  • Vigilance drafting
  • Training delivery

SharePoint or Google Workspace QMS Sites

Basic Framework

  • Site structure
  • Document libraries with metadata
  • Retention rules
  • Controlled templates
  • One workflow (Change Control)

Plus

  • Adds 3–5 workflows (CAPA, NC, Complaint triage)
  • Dashboards
  • Role-based permissions
  • Audit workspace
  • Basic software validation pack

Turnkey QMS Implementation

  • Full A–G QMS template deployment
  • Site build
  • Migration of legacy documents
  • Workflow suite
  • Training curriculum
  • Pilot + go-live
  • QMS software validation execution evidence (per ISO 13485 clause 4.1.6)

Turnkey QMS Implementation (On-Prem or Cloud)

Includes:

  • End-to-end ISO 13485 QMS build
  • SOP deployment
  • Forms, registers, templates
  • Risk management system
  • Supplier lifecycle system
  • CAPA & NC
  • PMS + Vigilance
  • Training + competency system
  • Validation packs (URS/IQ/OQ/PQ)
  • Go-live readiness checklist
  • Hypercare window

Service Inclusions (All Tiers)

  • Project charter
  • Project plan
  • RACI
  • Status reporting
  • Readiness checklist
  • Go-live criteria
  • Hypercare period

Assumptions & Exclusions

  • Client provides applicable product regulatory details
  • Travel costs billed separately
  • Regulatory submissions excluded unless contracted
“Ultra-clean white-blue clinical workspace showing multiple digital QMS systems: SharePoint interface with document control tabs, Google Sites navigation panel, MDR GSPR matrix pages, FDA DHF/DMR/DHR mapping diagrams, and ISO 14971 risk analysis tables. Stainless-steel accents, sharp typography, minimal medical-device compliance aesthetic, no people.

ISO 13485 QMS on Microsoft 365

Transform your SharePoint environment into a validated Quality Management System. We configure document control, training, CAPA, and audit processes natively in Microsoft 365—eliminating paper and reducing compliance overhead.

  • SharePoint-based document control
  • Power Automate workflows for CAPA, NCR, and approvals
  • Integrated training and version tracking
Start Implementation
High-end regulatory documentation spread: controlled SOP templates, version-tracked SharePoint panels, Google Drive folder architecture, MDR technical documentation binder, FDA submission checklist sheets, and ISO 14971 hazard traceability matrix. Crisp white background, soft shadows, premium medical device compliance style.

ISO 13485 QMS on Google Workspace

For teams in Google Drive and Sites, we deliver an ISO 13485-aligned QMS that’s simple, collaborative, and audit-ready. Maintain full traceability through shared permissions and structured template libraries.

  • Controlled folder architecture & naming conventions
  • Google Sites front-end for process navigation
  • Template library for SOPs and records
Get Your QMS Audit-Ready
Modern multi-screen layout showing a consolidated compliance dashboard: Power Automate workflow diagrams, Google Sites QMS homepage, MDR GSPR table, FDA QMSR vs ISO 13485 gap matrix, and risk management FMEA sheet. Blue-white lighting, minimal UI elements, polished corporate regulatory aesthetic, no human figures.

EU MDR & IVDR Compliance

Guidance and documentation for European market access. We prepare GSPR mapping, Technical Documentation, Clinical Evaluation, and Post-Market Surveillance frameworks aligned to MDR 2017/745 and IVDR 2017/746.

  • GSPR mapping matrix
  • Tech file compilation & CER/PER templates
  • PMS & PMCF documentation
Map your MDR readiness
Structured technical display: validated SharePoint workflows, controlled Google Drive template library, MDR 2017/745 documentation sections, FDA DHF/DMR/DHR architecture charts, and ISO 14971 risk analysis documentation with hazard matrices. Clean clinical look, stainless-steel accents, precise shadows, zero clutter, no people.

FDA QMSR (21 CFR 820)

Align your QMS to FDA’s Quality Management System Regulation integrating ISO 13485 principles. We design DHF, DMR, DHR, and submission-ready documentation.

  • DHF/DMR/DHR structure mapping
  • QMSR vs ISO 13485 gap analysis
  • Submission documentation checklists
Prepare for FDA inspection
Ultra-clean white-blue clinical workspace featuring ISO 14971 and IEC 62366-1 documentation: open Risk Analysis worksheets, FMEA tables with severity/probability rankings, hazard traceability matrix, and usability validation plans. Include structured diagrams, decision trees, and interface mockups for usability testing. Stainless-steel accents, sharp typography, minimal medical device regulatory aesthetic, no people.

Risk & Usability Engineering

Develop risk management files and usability documentation that satisfy ISO 14971 and IEC 62366-1. We bridge engineering, clinical, and QA inputs into one coherent framework.

  • Risk Analysis & FMEA templates
  • Hazard traceability matrices
  • Usability validation plans
Strengthen your risk files

Why Work With Us

Our services convert regulatory requirements into controlled, operational systems. You receive structured outputs, audit-defensible records, and fully integrated systems aligned with ISO 13485, MDR and FDA expectations.

Our Engagement Model

  • 1. Assess

    Detailed review of your current documentation, processes, and regulatory landscape.

  • 2. Implement

    Configure your QMS, train users, and align technical documentation to applicable regulations.

  • 3. Prove

    Conduct internal audit simulation and hand-over validation evidence for certification or submission.
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