Services
FDA PMA Approval
Class III approval pathway for life-sustaining innovation.
FDA De Novo Classification
Risk-based pathway for first-of-kind low-to-moderate risk devices.
EU MDR Compliance
Regulation (EU) 2017/745 — full life-cycle compliance.
EU IVDR Compliance
Regulation (EU) 2017/746 — risk-based class A/B/C/D pathway.
Combination Products
Drug-device, biologic-device & device-led combinations — RFD to PAI.
Quality Management Systems
ISO 13485 / QMSR builds, remediations and harmonisation.
ISO 13485 Consulting
Implementation, certification and transition to ISO 13485:2016.
FDA QMSR Compliance
Transition from QSR (820) to harmonised QMSR by 2 Feb 2026.
Diagnostics & IVD Consulting
IVDs, LDTs, companion diagnostics — FDA & EU IVDR.
Pharma & Biotech Regulatory
INDs, NDAs, BLAs and global submissions.
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