ISO 13485 Medical Devices Quality Management Systems Consulting
Your Path to ISO13485 Success
Implement, certify, and scale a medical grade QMS—without the chaos. Dreig helps MedTech teams build ISO
13485–compliant quality systems that stand up to auditors, accelerate market access, and reduce risk across the
device lifecycle.
Who We Help
Manufacturers, OEMs, contract manufacturers, start ups/scale ups, SaMD/AI enabled devices, IVD,
distributors, and importers across Australia, the USA, EU/UK, and APAC
Outcomes You Can Expect
Certification ready QMS aligned to ISO 13485 with embedded risk management (ISO 14971).
FDA QMSR transition plan for 21 CFR 820 modernization (effective 2 Feb 2026).
MDSAP readiness covering Australia, Brazil, Canada, Japan, and the USA.
EU MDR/IVDR & TGA alignment for technical documentation, PMS, and vigilance.
Audit confidence through internal audits, CAPA strength, and management review discipline.
1) Readiness & Strategy
Gap assessment against ISO 13485 & applicable regs (FDA QMSR, EU MDR/IVDR, TGA).
Risk posture review and ISO 14971 integration across the QMS.
Certification roadmap, resource plan, and auditor style risk register.
2) QMS Build (or Rebuild)
Quality Manual & Policy hierarchy tailored to your device portfolio.
Core SOPs & records including document control, training/competence, design & development controls,
purchasing/supplier controls, production & process control, equipment maintenance & calibration, sterile process
& validation, software validation, traceability & UDI, complaint handling, nonconformance, CAPA, internal audits,
management review, PMS & vigilance.Design controls toolset: DHF/DMR/DCF templates, usability, verification/validation, change control.
Supplier quality management: evaluation, approval, monitoring, and SCARs.
Data integrity & cybersecurity considerations for SaMD/connected devices.
3) Implementation & Training
Team training for leadership, QA/RA, engineering, production, service.
Pilot runs of change control, NC/CAPA, and internal audits.
Calibration of KPIs & QMS metrics; management review pack.
4) Certification & Market Access Support
Preassessment (‘mock audit’) and closure of findings.
MDSAP audit preparation and NB/AO liaison.
FDA QMSR transition coaching and evidence mapping to ISO 13485 clauses.
Our Consulting Approach
Assess (2–4 weeks): Evidence review, site walkthroughs, stakeholder interviews, gap & risk reports.
Build (4–12 weeks): Draft, iterate, and approve the Quality Manual + SOP suite; stand up records and logs.
Embed (2–8 weeks): Train teams, run internal audits, prove the CAPA loop, and tune KPIs.
- Certify & Scale: Preassessment, corrective actions, auditor liaison, and handover into BAU.
Regulatory Coverage
ISO 13485:2016 (QMS for medical devices) with ISO 14971 risk integration.
FDA QMSR (replaces QSR/21 CFR 820) — effective 2 Feb 2026.
MDSAP member markets: Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW/PMDA),
USA (FDA).EU MDR/IVDR technical documentation, PMS/PMCF, vigilance & PSUR.
Example Deliverables
Quality Manual + 20–40 SOPs (scopedependent)
DHF/DMR templates, design & change control forms
Risk management plan, hazard analysis (FMEA/FTA), risk/benefit reports
Supplier QA package (approval, monitoring, SCAR)
Production & process validation protocols/reports (incl. software/CSV)
Internal audit program & checklists; CAPA register; management review pack
PMS plan, complaint handling workinstructions, vigilance workflows
eQMS configuration/user training pack (if applicable)
Why Dreig
Devicesavvy: Processes tuned to your design controls and manufacturing reality.
Auditready documentation: Clear traceability from policy → procedure → record.
Scalable: Start lean; scale to MDSAP and multisite as you grow.
Global lens: Build once, comply in multiple markets.
FAQs
How long does ISO 13485 certification take? Typical small/medium teams achieve certification in 3–6 months
postkickoff—faster with strong internal ownership.
Do we need ISO 14971 if we’re doing ISO 13485? Yes—risk management is embedded throughout ISO 13485
and is expected by regulators.
What changes with FDA’s QMSR? QMSR aligns Part 820 with ISO 13485 and becomes effective 2 Feb 2026;
we map your QMS evidence to the new expectations.
Which countries does MDSAP cover? Australia, Brazil, Canada, Japan, and the USA; one audit supports all five
authorities.
Can you work with our eQMS? Yes—whether you’re on a commercial eQMS or a pragmatic document stack, we
validate and rightsize to your risk profile.
