About us
About Confiquora
We help medical device and diagnostics manufacturers, testing laboratories and healthcare providers meet the regulations that stand between their product and their market.
Last updated: November 2026
What we do
Confiquora is a regulatory affairs and quality-management consultancy. We build quality management systems, prepare technical documentation, and run the submissions that bring a product to market in India, the European Union and the United States. We work with manufacturers of medical devices and in-vitro diagnostics, with testing and calibration laboratories, and with hospitals and clinics seeking accreditation.
Our practice areas
- Quality Management Systems — ISO 13485 and ISO 9001 implementation, GMP quality systems, internal audits and CAPA.
- Regulatory Approvals — CDSCO licensing, EU MDR and IVDR CE marking, FDA 510(k) and PMA, MDSAP.
- Laboratory and Healthcare Accreditation — NABL (ISO/IEC 17025 and ISO 15189) and NABH.
- Technical Documentation — technical files, design history files and clinical evaluation reports.
- Validation and Risk — IQ/OQ/PQ, computer system validation and ISO 14971 risk management.
- Training — internal auditor certification and practitioner-led programmes, online or onsite.
Alongside consulting we publish audit-ready document template packs, and we are developing Confiquora QMS, a subscription tool for running document control and CAPA. See pricing for what is available today.
How we work
Every engagement starts with a free 30-minute consultation in which we map your product, your target markets and your timeline. You then receive a written proposal setting out scope, deliverables, fees and schedule. Nothing is chargeable until you accept that proposal in writing.
Business details
| Business name | Confiquora Global |
|---|---|
| GSTIN | 09AWKPP9795K1ZA |
| connect@confiquora.com | |
| Telephone | +91 97115 29295 |