HeiMed Information

I help small and medium-sized manufacturers with MDR-compliant documentation, specializing in 𝗖𝗹𝗮𝘀𝘀 𝗜𝗜𝗮, 𝗜𝗜𝗯, 𝗮𝗻𝗱 𝗜𝗜𝗜 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀: 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻𝘀, 𝗣𝗼𝘀𝘁-𝗠𝗮𝗿𝗸𝗲𝘁 𝗦𝘂𝗿𝘃𝗲𝗶𝗹𝗹𝗮𝗻𝗰𝗲, 𝗮𝗻𝗱 𝗠𝗗𝗥 𝗖𝗼𝗻𝘀𝘂𝗹𝘁𝗶𝗻𝗴 – focused on practicality and audit readiness. 𝗠𝘆 𝗺𝗮𝗶𝗻 𝗮𝗿𝗲𝗮𝘀 𝗼𝗳 𝗲𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲 𝗶𝗻𝗰𝗹𝘂𝗱𝗲: • Clinical evaluation of medical devices (CEP / CER) • Post-Market Clinical Follow-up (PMCF, incl. development of study designs) • Post-Market Surveillance (PMS, PSUR, SSCP) • Risk management according to ISO 14971 • MDR-compliant technical documentation • Preparation and support of CE certification processes Competences: 𝗢𝗽𝗵𝘁𝗵𝗮𝗹𝗺𝗼𝗹𝗼𝗴𝘆, 𝗗𝗲𝗿𝗺𝗮𝘁𝗼𝗹𝗼𝗴𝘆, 𝗢𝗿𝘁𝗵𝗼𝗽𝗮𝗲𝗱𝗶𝗰𝘀, 𝗗𝗲𝗿𝗺𝗮𝘁𝗼𝗹𝗼𝗴𝘆, 𝗚𝘆𝗻𝗮𝗲𝗰𝗼𝗹𝗼𝗴𝘆, 𝗖𝗮𝗿𝗱𝗶𝗼𝗹𝗼𝗴𝘆 Products: 𝗶𝗺𝗽𝗹𝗮𝗻𝘁𝘀, 𝘀𝘁𝗲𝗿𝗶𝗹𝗲 𝘀𝗶𝗻𝗴𝗹𝗲 𝘂𝘀𝗲 𝗱𝗲𝘃𝗶𝗰𝗲𝘀, 𝗱𝗶𝘀𝗽𝗼𝘀𝗮𝗯𝗹𝗲𝘀, 𝗲𝗹𝗲𝗰𝘁𝗿𝗼𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀