David Busk

Background

About David Busk

I have 12 years of experience in EMC, radio, and safety testing, and I am highly motivated and results driven. As an Approvals Specialist at 3Shape, I ensure our products meet stringent medical regulatory standards. My responsibilities include overseeing certifications, documentation, pre-testing, and providing safety and EMC support to developers. I have managed the operation of an accredited test laboratory in compliance with ISO/IEC 17025 standards. I was actively involved in all phases of product approvals, including consultancy, test planning, creating quotes, conducting tests, project management, and writing/reviewing reports. My duties included quality assurance, developing test procedures, managing uncertainty budgets, and ensuring the calibration of relevant equipment. Additionally, I served as the primary contact for regulatory agencies such as DANAK (Denmark), FCC (USA), ISED (Canada), and VCCI (Japan). Experience: • Ensuring products meet medico regulatory standards and certifications. • Providing general safety support (IEC 60601-1) and EMC support (IEC 60601-1-2). • Ensuring compliance with global radio standards (ETSI, FCC, ISED, etc.). • Assisting with technical IFUs, risk management, and regulatory processes. • Performing accredited CE marking testing (EMC and RED), FCC testing, and ISED testing. • In-depth knowledge of EMC standards: EN, IEC, CISPR, FCC, ISED, VCCI. • Experienced within radio standards: ETSI, FCC, ISED. • Expert knowledge within many product family standards: Medico (IEC 60601-1 & IEC 60601-1-2), Marine (IEC 60945 & IACS UR E10), Multimedia, Laboratory, Alarm etc. • Project management for product approvals. • Maintenance and development of accredited testing facilities.