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About Emerging Sigma Consulting

25+ years of specialist expertise in Medical Device Quality & Regulatory Affairs, serving organizations across India and global markets.

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Who We Are

A boutique specialist consulting firm focused exclusively on Medical Device Quality Management and Regulatory Affairs, serving manufacturers, importers, distributors, and healthcare organizations in India and internationally.

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Our Mission

To build quality and regulatory systems that are not just compliant, but self-sustaining. Every solution is tailored to the client's specific processes, regulatory environment, and long-term operational goals.

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Our Vision

To be the most trusted quality and regulatory partner for medical device organizations in India, recognized for depth of expertise, integrity in approach, and the lasting compliance impact we deliver.

Company Overview

Specialist Consulting Built on Deep Regulatory Expertise

Emerging Sigma Consulting was founded with a clear purpose: to provide medical device and healthcare organizations with senior-level quality and regulatory expertise, without the overhead of large consultancy structures.

Our focus is deliberate and narrow: Quality Management Systems and Regulatory Affairs for medical devices. This focused approach allows us to go deeper, stay current, and deliver more precise outcomes than generalist consulting firms.

Every engagement is underpinned by a commitment to building systems that are lean, digitization-friendly, and self-sustaining, delivering value that extends well beyond the consulting engagement itself.

25+
Years Experience
10+
Global Markets
12+
Standards Covered

Our Consulting Approach

1
QMS Planning
Gap analysis, regulatory requirement mapping, and a tailored QMS roadmap.
2
System Development
Lean, digitization-ready documentation and process design across all business functions.
3
Implementation & Sustainment
Audit support, internal auditor training, and continuous improvement framework setup.
Leadership

Principal Consultant

Manish Airan, Principal Consultant, Emerging Sigma Consulting
Manish Airan
Principal Consultant
Emerging Sigma Consulting
Mumbai, India

Manish Airan brings over 25 years of hands-on experience in Regulatory Affairs, Quality Assurance, and Business Excellence across the Medical Devices, In-Vitro Diagnostics, and Global Automotive Components industries.

Core expertise spans global regulatory strategy and submissions, QMS design and certification support, data-driven process improvement, equipment qualification, and digitalization of compliance infrastructure, covering markets across India, Europe, the United States, Japan, Brazil, Canada, and WHO member states.

The consulting philosophy centers on creating quality and regulatory systems that are integrated, lean, digitization-friendly, and self-sustaining, designed to deliver lasting compliance value well beyond the engagement period.

Engagements are taken on in small numbers so that each one gets senior attention throughout, rather than being handed down once the proposal is signed.

ISO 13485 QMS EU MDR / IVDR CDSCO MDR 2017 US FDA 21 CFR 820 WHO PQ Six Sigma Black Belt Supplier Quality Equipment Qualification Risk Management ISO 14971 Internal Auditing Lean Process Improvement eQMS Digitalization
Certification
ASQ Certified Manager of Quality / Organizational Excellence (CMQ/OE)
Certification
ASQ Certified Six Sigma Black Belt
Certification
ISO 13485 and ISO 9001 Lead Auditor
Certification
VDA 6.3 Process Auditor
Alumni
BITS Pilani and IIM Calcutta
Specialized Training
Medical Statistics, Stanford University
Technical Expertise

Standards & Regulatory Frameworks

ISO 13485:2016 (Medical Device QMS)
EU MDR 745 / IVDR 746
US FDA 21 CFR 820 / QMSR
CDSCO MDR 2017 (India)
WHO Prequalification (PQ)
PMDA (Japan) · ANVISA (Brazil) · Health Canada
ISO 14971 (Risk Management)
ISO 9001 · IATF 16949 · MDSAP
GAMP 5 · FDA 21 CFR 11
EU GMP Annex 1 · WHO TRS 961
GxP (GMP, GLP, GDP)
ISO/IEC 17025:2017
25+Years of Experience
10+Global Markets
4Practice Areas
12+Standards Mastered