CONTACT PERSON
Willibrord Driessen
Qserve Consultancy BV is an independent Regulatory Compliance Consultancy Company, having an office in Europe (Amsterdam, the Netherlands).
Qserve's experts offer assistance/support in Strategic planning/development, Due diligence & GAP Analysis services, Product regulatory clearance (such as CE MARK, 510K, IND, PMA and more), preclinical, clinical support services, certified training, auditing (internal, supplier and distributor) and quality management systems implementation (ISO 13485 including Canadian CANCAS, FDA Quality Regulations (P5R, part $820). Preclinical studies, Planning of Electrical safety tests, Biocompatibility tests, Physical and mechanical tests, Animal studies, Stability/ shelf life testing and Sterilisation validation tests. Clinical Evaluation Studies, strategy, advice on and review of clinical investigation plans and clinical study protocols, investigators brochures, Selection of suitable physical testing, Writing your clinical procedures, Shelf life study, Clinical literature studies, Risk & Benefit studies, Post market clinical follow‐up (PMCF), Selection of Clinical Research Organisations and Agencies (CRO's & CRA's).