Quality Management Systems & Quality Engineering

Build audit-ready, scalable quality systems. We implement, harmonise and sustain QMS for ISO 13485, FDA QMSR, MDSAP and national schemes, and support the quality engineering behind design controls and risk management.

ISO 13485:201621 CFR 820 · QMSRMDSAPISO 14971:2019ISO/TR 24971IEC 6230421 CFR Part 11

QMS implementation & certification

Turnkey ISO 13485 implementation for new companies and sites, with ISO 9001:2015 where needed
Process maps and QMS workflow design
Quality manual, procedures, work instructions and templates
Document control and change management
Certification audit preparation, hosting and liaison

FDA QMSR readiness

QMSR has applied since 2 February 2026. Legacy QSR records often need reconciling with ISO 13485 structure and terminology.

QSR-to-QMSR gap assessment and remediation roadmap
Reconciliation of legacy DHF, DMR and DHR records with the medical device file and other ISO 13485 records
Risk management integrated across processes per ISO 14971
Supplier agreements, controls and audits
Labelling and packaging controls
Readiness for QMSR-based FDA inspections

21 CFR 820ISO 13485:2016

QMSR readiness page →

QMS transformation & harmonisation

Enterprise-wide gap analysis and maturity modelling
One QMS across multiple legal entities and sites
eQMS selection, configuration, validation and migration
Computerised system compliance to 21 CFR Part 11 and EU GMP Annex 11
Quality KPI dashboards and management review
Change management and quality culture programmes

Audits & inspection readiness

Risk-based internal audit programmes
Mock Notified Body, IVDR, MDSAP and FDA audits
Front-room and back-room support during live audits
Responses to audit findings, FDA 483s and warning letters
Post-audit CAPA planning and effectiveness checks

QMS sustenance

Outsourced or co-sourced, so your system stays current between audits.

Periodic QMS maintenance and procedure updates
CAPA, change control and nonconformance administration
Management review inputs and records
Training and competency records
Supplier performance scorecards

Design quality engineering

Design controls, design reviews and traceability
DHF and DMR gap analysis and remediation
Product documentation for new product introduction
Verification documentation and real-time ageing data analysis
Root cause analysis and continuous improvement projects
Configuration management: ECOs, DCOs, BOM control and GDP

Product risk management

Risk management plan and framework design
Hazard analysis, DFMEA, PFMEA and use-related risk analysis
Risk-related gap assessment and IFU gap analysis
Benefit–risk determination and risk management report
Production and post-production feedback into the risk file

ISO 14971:2019ISO/TR 24971:2020

Software quality engineering

IEC 62304 lifecycle compliance
Software verification and validation documentation
Configuration and release management
DevOps migration with controlled change
Cybersecurity compliance documentation

Supplier quality & supply chain

Supplier qualification and lifecycle management
Global supplier audit programmes
Quality agreements and supplier relationship management
Supply chain resilience and QMS business continuity

Remediation & crisis support

Urgent remediation task force after a critical finding
Executive support and regulator liaison
Consent decree readiness
FSCA and recall coordination with our PMS team

Training & competency

ISO 13485, ISO 14971, IEC 62304, EU MDR and IVDR, FDA and RoW regulations
PRRC training for manufacturers and economic operators
Train-the-trainer and certification-track bootcamps
Delivered on site or through LMS-based modules

Quality packages

Defined engagements with clear outputs

Start with a package and extend it as you need. Each has a defined scope, method and set of outputs.

Moving from QSR to QMSR

QMSR Readiness Assessment

Scope: Procedures, records and one design file
Outputs: Gap report, prioritised plan, readiness summary
Method: Document review, interviews, record sampling

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Startups and new sites

ISO 13485 Implementation

Scope: Process architecture, procedures, records, training
Outputs: Certification-ready QMS, first internal audit and management review
Method: Phased build, pilot, internal audit, certification support

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Upcoming NB, MDSAP or FDA audit

Audit Readiness Programme

Scope: Mock audit, CAPA, staff preparation
Outputs: Mock audit report, CAPA plan, front- and back-room plan
Method: Audit simulation using the auditor's methodology

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No full-time QA capacity

Outsourced QMS Support

Scope: CAPA, change control, complaints, document control, management review
Outputs: Maintained QMS with monthly KPI reporting
Method: Dedicated or shared specialists under agreed service levels

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Global QMS frameworks

The quality requirements we operationalise

One harmonised system can satisfy most of these at once. We design the process architecture so each additional market adds records, not a parallel system.

Framework	Jurisdiction	Reference
ISO 13485:2016	International	Medical devices · QMS requirements
Quality Management System Regulation	United States	21 CFR Part 820
EU MDR and IVDR QMS obligations	European Union	Article 10 · Annex IX
Medical Device Single Audit Program	AU · BR · CA · JP · US	MDSAP
Medical Devices Rules, Fifth Schedule	India	CDSCO · MDR 2017
Good Manufacturing Practice	Brazil	ANVISA RDC 665/2022
QMS Ordinance	Japan	MHLW Ministerial Ordinance No. 169
KGMP	South Korea	MFDS
Quality Management System requirements	Taiwan	TFDA QMS
UK MDR 2002 and UKCA marking	United Kingdom	MHRA

Talk to our experts

Discuss your device, market or audit with a specialist

Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.

Talk to our experts → Request an AI pilot sales@medoqi.tech · +91 44 4690 0555