FDA 510(k) Clearance
Predicate strategy, eSTAR authoring, substantial equivalence and FDA correspondence.
Medical Devices
Class I, II, III devices — from concept to global commercialisation.
How we serve Medical Devices.
We support medical device manufacturers across the full product lifecycle — from early classification and predicate strategy to FDA 510(k), De Novo, PMA, EU MDR Technical Documentation, ISO 13485, QMSR readiness, design controls, risk management, verification and validation, supplier controls, CAPA, PMS and audit defense.
Our value is regulatory precision with engineering depth. We help teams translate complex device evidence into clean, reviewer-ready narratives that withstand FDA review, Notified Body scrutiny, investor diligence and post-market inspection.
FDA 21 CFR Part 820 / QMSR
FDA 510(k), De Novo and PMA pathways
EU MDR 2017/745
ISO 13485:2016
ISO 14971:2019
IEC 62366-1 Human Factors Engineering
IEC 62304 Medical Device Software
MDSAP
Where we typically engage with Medical Devices clients.
Service detail
FDA De Novo Classification
Risk-based pathway for novel low-to-moderate risk medical technologies.
EU MDR Compliance
Technical Documentation, GSPR, PMS, PMCF and Notified Body readiness.
Quality Management Systems
ISO 13485 / QMSR builds, remediation and inspection-ready quality systems.