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