H&A Clinical

H&A Clinical is a trusted partner for medical devices for everything from pre-market to post-market and all clinical research services in between. CLINICAL RESEARCH ORGANISATION (CRO) SERVICES IN AUSTRALIA: - Essential Documentation writeup: Clinical Investigation Protocol (CIP), Investigator Brochure (IB) per ISO 14155 or ICH GCP - CRF and worksheet design - Study close out - Clinical field specialist support: clinical education and training, in-field support - Regulatory & administrative support: HREC, RGO, CTN submissions - Study monitoring and project management: SDV, SDR, safety reporting, study compliance - Study oversight management: convening Investigator meetings, Data Safety/Monitoring Boards, KOL engagement R&D - TECHNICAL & CLINICAL SERVICES - Product design & development - Prototyping and design for manufacture (DFM) - Verification and validation (V&V) - Production planning - Risk management file (hazard analyses, design/user/process FMEAs) - Clinical Evaluation Plan/Report (CEP/CER) writing - Technical File development - Manuscript writing/preparation for scientific journals QUALITY MANAGEMENT & REGULATORY - Regulatory & market access strategy (CE and TGA) - QMS design and implementation (ISO 13485, 21 CFR 820) - Regulatory submissions – conformity assessment (CE and TGA) - Support for Notified Body/Competent Authority audits - Post-market surveillance and regulatory reporting BUSINESS CONSULTING - Product commercialisation strategy - Product launch strategy - Device funding and commercialisation - Technical training: GMP (ISO 13485), CGP (ICH-GCP and ISO 14155) - Grant writing and application preparation - Clinical and Engineering teams setup and mobilisation (Fractional COO or GM consulting)