Innovation Dynamics BV

Our mission is to be your partner in MedTech, guiding you through the challenges and complexities of growing your business. We provide hands on advisory and execution services for your clinical, compliance and business needs. Clinical Services: - Clinical trail design, planning & execution - Medical writing - Post market clinical studies (Healthcare/ Medical Device) Compliance Services: - MDR 2017/745 Technical documentation writing and reviewing - IEC 62304 Medical device software - IEC 60601 Medical electrical equipment - ISO 13485: 2016 Implementation and audits - MDSAP Implementation and audits - ISO 14155 Clinical investigations and evaluations - ISO 42001 Artificial Intelligence Management System (AIMS) - ISO 27001 Information & Cyber security - UKCA Compliance - CAPA Management and hands-on support - Audit preparation - Independent 3rd party audits - Audit outcome implementation - Interim QA/ RA support Business consulting services: - Investment readiness - (Independent) Business review & recommendations for VC or PE funds - Hands-on go to market support - Interim (CxO) positions - Special projects Cybersecurity for Medical Devices and Software: - IEC 81001-5-1 - MDCG 2019-16 r1 - FDA Cybersecurity guidelines - Pen testing