Our Services

Market entry strategy through to post-market obligations, with India and CDSCO as our primary depth and EU, US and other markets alongside.

• CDSCO MDR 2017 licensing across manufacturing, import, wholesale and test
• EU MDR 745 and IVDR 746 technical files and CE marking
• US FDA 510(k), PMA and QMSR compliance
• WHO PQ, PMDA, ANVISA, Health Canada, BIS certification
• Clinical investigation and performance evaluation
• Post-market surveillance, PSUR and licence renewals

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One quality architecture rather than a folder per standard, covering the management system itself and the four areas where it has to hold in practice.

• Quality Management SystemISO 13485, MDSAP and CDSCO-aligned systems built to be audited and to be used
• Product Quality ManagementQuality decided in development, from NPD through in-process and finished goods control
• Equipment QualificationDQ, IQ, OQ and PQ, calibration and computerised system validation
• Supplier Quality ManagementSupplier selection, qualification, performance and capability building
• Warehouse & LogisticsReceiving, storage, handling and distribution controls that keep material conforming

Distinguishing process problems from digitalization problems, then taking the second kind from data-backed problem statement to build-ready specification.

• Quality, regulatory, supply chain and operations systems
• Clickable prototypes before any code is written
• Build-ready PRDs with data dictionary and acceptance criteria
• Compliance and data integrity designed in from the start

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Four-level curriculum with independent evaluation, a defined pass mark and a retraining loop, because attendance records prove nothing about competence.

• QMS fundamentals through to Six Sigma and DOE
• Independent competency evaluation with section-wise diagnosis
• Train-the-trainer for process owners
• Internal auditor development and regulatory awareness

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