Services – QM Service global

ISO Certification Consultancy

International Management System Standards

Implementation, documentation, training, audit preparation, and certification support for ISO 9001, ISO 14001, ISO 13485, ISO 22000, and ISO 45001 management system standards across industries.

CE Marking Consultancy – EU MDR

European Regulatory Compliance

Complete consultancy services for medical device manufacturers seeking CE Marking under EU MDR 2017/745, including technical documentation, compliance support, and market access guidance.

EU REP & EUDAMED Registration

Your Official Representative in Europe

Support for EU Authorized Representative appointment, EUDAMED registration, UDI creation, regulatory documentation, and ongoing compliance for medical devices in European markets.

IMDR / CDSCO Regulatory Consultancy

Indian Medical Device Compliance

Professional regulatory support for manufacturing licenses, product registrations, technical documentation, compliance reviews, and coordination with CDSCO and licensing authorities.

BIS / ISI Mark Certification

Quality Standards for India

Consultancy services for BIS certification and ISI Mark approvals, including documentation preparation, product testing coordination, regulatory guidance, and compliance support.

US FDA Regulatory Consultancy

Gateway to the United States Market

Guidance and documentation support for FDA establishment registration, device listing, regulatory submissions, compliance requirements, and successful entry into the U.S. market.

South Africa Medical Device Regulatory Compliance

SAHPRA Regulatory Support

We provide end-to-end regulatory support for medical device registration in South Africa, including regulatory gap analysis, SAHPRA portal submissions, scientific query resolution, and post-registration maintenance.

SFDA Medical Device Registration (MDMA)

Saudi Arabia Market Access

Regulatory consultancy support for SFDA Medical Device Marketing Authorization (MDMA), product registration, documentation preparation, and compliance for Saudi market entry.

Sedex / SMETA Certification Consultancy

Ethical Trade & Supply Chain Compliance

Implementation and audit preparation support for Sedex and SMETA requirements, helping organizations demonstrate ethical sourcing, social responsibility, and supply chain transparency.

ZeD Certification Consultancy

Zero Defect Zero Effect Excellence

Consultancy support for ZED Certification, enabling Indian MSMEs to improve product quality, operational efficiency, environmental sustainability, and global competitiveness.

UKCA Certification

United Kingdom Market Compliance

We provide complete consultancy support for UKCA marking, helping manufacturers meet United Kingdom regulatory requirements for product compliance, documentation, conformity assessment, and market access after Brexit.

FSC - Certificate

Free Sale Certificate – FSC

An EU Certificate of Free Sale (CFS) is an official document issued by a European Competent Authority, verifying that a manufacturer’s medical device or product complies with EU regulations and can be legally marketed and freely sold within the European Economic Area (EEA)

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