OUR EXPERTISE / YOUR NEXT STEP
Strong systems.
Confident progress.
A focused range of consultancy and auditing services, with the expertise of Aravind Bhatta, Head of Regulatory Office.
Consultancy & management
- Lean Six-Sigma Quality Management
- Risk Assessment, Planning and Management
- Regulatory Compliance Consultancy (CDSCO, ABDM, DPDP)
- International Data Protection and Privacy Management
- Global Patent Search and Analysis
- AI Ethics and Governance
ISO auditing for management systems
- ISO 9001:2015QMS
Quality management
- ISO/IEC 27001:2022ISMS
Information security management
- ISO/IEC 27701:2025PIMS
Privacy information management
- ISO/IEC 42001:2023AIMS
AI management
- ISO 13485:2016MDQMS
Medical device quality management
With the expertise ofAravind BhattaHead of Regulatory Office
01 / ABDM
Connect your systems. Support continuity of care.
Bring your digital health workflows closer to the Ayushman Bharat Digital Mission ecosystem. Talk to us about integration planning and technical implementation support.
Areas we can discuss
- Integration and workflow assessment
- ABHA and consent-based health information workflows
- Sandbox testing and implementation planning
A typical engagement Explore the steps
Review existing systems, information handovers, and the ABHA and consent workflows relevant to your organisation.
Define integration points, responsibilities, and a sandbox testing plan around the agreed workflow.
Test agreed scenarios, review exceptions, and identify what is needed before implementation.
02 / DPDP
Build privacy into the way you work.
Translate data protection requirements into practical workflows. Explore readiness and implementation support for your organisation’s approach to digital personal data.
Areas we can discuss
- Personal data mapping and readiness review
- Notice, consent, and request-handling workflows
- Operational controls and implementation planning
A typical engagement Explore the steps
Map where personal data enters your systems, how it is used, and who handles it.
Review notices, consent, requests, and operational controls in the context of your organisation.
Define responsibilities, document workflows, and plan how the team will maintain and review them.
03 / ISO 13485
Make quality part of every process.
Create a clearer path towards a medical device quality management system. Discuss support for process definition, documentation, and readiness aligned with ISO 13485.
Areas we can discuss
- Quality management gap assessment
- Process and documentation support
- Internal audit and certification readiness planning
A typical engagement Explore the steps
Review your existing quality processes and identify the areas that need attention.
Define processes, responsibilities, and documentation around your medical device quality management needs.
Use internal review and audit preparation to identify gaps and plan follow-up actions.
Engagement scope is agreed after reviewing your systems and requirements. Advisory and implementation support do not constitute regulatory approval, legal advice, or certification.
YOUR NEXT CHAPTER STARTS HERE
Let’s make room
for better care.
Explore our products, discuss a service, or bring us a healthcare problem worth solving. Let’s find the right next step together.
- Your priorities and current workflows
- Relevant products and services
- A practical next step
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