Mdrc Aps

Kristoffer Madsen here DM: I am specialised in medical devices regulatory compliance and market access. I cover all main phases of Class I, Class IIa and Class IIb product development and maintenance with an enhanced focus on Medical Device Software (Stand-alone, embedded or as an accessory). I have extensive knowledge of the regulatory landscape and market access requirements for medical devices in key markets such as: EU, US, Japan and Canada. This includes ensuring compliance with various industry standards, including but not limited to: ISO13485, ISO14971, IEC62304 and IEC82304. Competences and Services- MDSW/SaMD Life Cycle Management & Regulatory Strategy - Digital Therapeutics (DTx) & Digital Reimbursement - Medical Device Infrastructure (QMS, ISMS, Audit Management)- Project Management and Systems Engineering - Quality Assurance and Design Assurance - Design Control - Risk Management - Requirements Engineering / mngt- Usability Engineering - Design Verification and Validation - Technical Writer - Design Input/output deliverables - Test Protocols and reports Regulations- MDR (EU) 2017/745 - GDPR (EU)- The German Digital Health Applications (DiGA)- US, FDAs 21 CFR part 812, part 820 and part 860 - US, HIPAA Standards- ISO 13485 - ISO 14971 (+ISO/TR 24971:2020)- IEC 62304 - IEC 82304 - IEC 62366-1 and 62366-2 eDMS/eQMS Knowledge- GreenLight Guru - Veeva Vault - MasterControl