About QMS

Global Regulatory Intelligence • Quality Excellence • International Market Access

Professional Quality Management System & Regulatory Consultancy Services Across India, Europe, USA, Africa, UAE & Saudi Arabia

Who We Are

QMS (Quality Managment Service) is a professional Quality Management System and Regulatory Consultancy organization, having Head Quarters in Kottayam, Kerala, India, and regional offices in Bengaluru and Delhi. Our international network extends through Denmark (Europe), Illinois (USA), Durban (South Africa), Ajman (UAE), and Jeddah (Saudi Arabia).

We provide specialized consultancy services to industries across manufacturing, healthcare, medical devices, food processing, engineering, and service sectors.

  • Head Office – India

    Kottayam, Kerala, India

  • Regional Offices

    Bengaluru & Delhi

  • International Presence

    Denmark • USA • South Africa • UAE • Saudi Arabia

Committed To Global Compliance Excellence

Our organization is committed to helping companies establish internationally recognized management systems, comply with regulatory requirements, and successfully access global markets.

With extensive expertise in international standards and regulatory frameworks, we support organizations in implementing structured management systems, improving operational efficiency, and achieving certification with confidence.

We offer end-to-end consultancy support, including system implementation, regulatory documentation, certification audit preparation, and international market compliance.

System Implementation

Complete implementation of management systems aligned with international standards.

Regulatory Documentation

Preparation of technical files, compliance records, and regulatory submissions.

Audit Preparation

Certification audit readiness and international market compliance support.

Global Consultancy Operations

Our consultancy operations extend across India, the Middle East, Europe, Africa, and the United States, assisting organizations in meeting global quality and regulatory expectations.

Management system certification helps organizations demonstrate that their processes, documentation, and operations conform to internationally recognized standards for quality, safety, environmental responsibility, and regulatory compliance.

Our Core Consultancy Services

Comprehensive consultancy and regulatory support designed for global market access.

ISO Certification Consultancy

Support for:  ISO 9001 –  ISO 14001

ISO 13485 – ISO 22000 – ISO 45001

CE Marking Consultancy – EU MDR

Comprehensive support for medical device manufacturers seeking CE Marking under EU MDR 2017/745 for European Union market access.

EU REP & EUDAMED Registration

EU Authorized Representative appointment, EUDAMED registration, Basic UDI-DI creation, and regulatory compliance support.

IMDR / CDSCO Regulatory Consultancy

Professional support for medical device manufacturing licenses, product registration, and liaison with licensing authorities.

BIS / ISI Mark Certification

Consultancy services for BIS certification and ISI Mark approval for regulated medical devices and healthcare products.

US FDA Regulatory Consultancy

Establishment registration, device listing, regulatory submissions, and compliance support for the United States market.

SFDA Medical Device Registration

Saudi Food and Drug Authority Medical Device Marketing Authorization (MDMA) consultancy services.

Sedex / SMETA Certification

Implementation and audit preparation support for ethical business practices and supply chain transparency.

ZeD Certification Consultancy

Zero Defect Zero Effect (ZED) Certification support for Indian MSMEs to improve quality and global competitiveness.

Our Mission

To support organizations in building robust management systems, achieving regulatory compliance, and expanding successfully into international markets through professional consultancy services.

Our Vision

To become a trusted global partner for quality management and regulatory consultancy services.

Ready To Expand Into Global Markets?

Partner with QM Service Global for international certification, regulatory compliance, and global market access solutions.