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Let us introduce ourselves

Global Regulatory Intelligence Simplified

We are a professional Quality Management System and Regulatory Consultancy organization, having Head Quarters in Kottayam, Kerala, India, and regional offices in Bengaluru (India), Delhi (India), also with overseas offices in Denmark-Europe, Illinois-USA, Durban-South Africa, Ajman-UAE, and Jeddah-Saudi Arabia, providing specialized consultancy services to industries across manufacturing, healthcare, medical devices, food processing, engineering, and service sectors.

Quality Management Service is a professional international regulatory consultancy organization helping manufacturers, medical device companies, healthcare organizations, pharmaceutical businesses, and exporters achieve global compliance and market access.

With offices and consultancy support across India, Europe, USA, Middle East, and Africa, we help organizations successfully navigate complex international regulations and certification requirements.

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ISO Certification Consultancy Services

Implementation and certification support for international management system standards including ISO 9001 (Quality Management System), ISO 14001 (Environmental Management System), ISO 13485 (Medical Device Quality Management System), ISO 22000 (Food Safety Management System), and ISO 45001 (Occupational Health & Safety Management System).

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CE Marking Consultancy – EU MDR

Complete consultancy services for medical device manufacturers seeking CE Marking under EU MDR 2017/745, enabling product exports to European Union countries.

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EU Authorized Representative (EU REP) Services

Support for appointment of EU Authorized Representative, and regulatory compliance for medical devices marketed in the European market.

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EUDAMED Registration / SRN Registration / UDI Generation

Support for EUDAMED registration, SRN Registration, Basic UDI-DI / UDI-DI / UDI-PI creation, and regulatory compliance for medical devices marketed in the European market.

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IMDR / CDSCO Regulatory Consultancy

Professional regulatory support for medical device manufacturing license approvals under Central Drugs Standard Control Organization, including documentation preparation, product registration, and liaison with State and Central Licensing Authorities.

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BIS / ISI Mark Certification Consultancy

Consultancy services for obtaining Bureau of Indian Standards certification and ISI Mark approval, particularly for regulated medical devices and healthcare products.

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US FDA Medical Device Regulatory Consultancy

Guidance and documentation support for compliance with U.S. Food and Drug Administration regulations, including establishment registration, device listing, and regulatory submissions for the United States market.

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SFDA Medical Device Registration (MDMA)

Regulatory consultancy support for Saudi Food and Drug Authority Medical Device Marketing Authorization (MDMA) to enable medical device market access in Saudi Arabia.

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Sedex / SMETA Certification Consultancy

Implementation and audit preparation support for Sedex / SMETA Audit, enabling organizations to demonstrate ethical business practices, responsible sourcing, and supply chain transparency.

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ZeD Certification Consultancy

Consultancy support for Zero Defect Zero Effect (ZED) Certification, helping Indian MSMEs improve manufacturing quality, environmental responsibility, and global competitiveness.

Your Trusted Partner for Global Regulatory Success

Why Choose QMS ?

At QMS, we combine regulatory expertise, industry knowledge, and practical implementation support to help manufacturers achieve compliance efficiently and confidently. Our structured approach minimizes risks, accelerates approvals, and ensures successful market access across international jurisdictions.

Reduced Risk of Rejection

Our experts conduct comprehensive document reviews and gap assessments to identify potential compliance issues before submission, significantly reducing the likelihood of regulatory rejection and costly delays.

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Faster Approval Timelines

With extensive experience in global regulatory frameworks and authority requirements, we streamline the submission process, helping clients achieve approvals faster and enter markets more efficiently.

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Dedicated Project Support

Every project is managed by a dedicated regulatory team that provides personalized guidance, regular updates, and complete support from initial assessment through final approval.

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Our Clients

 
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