The healthcare and medical technology industries are among the most strictly regulated. Software approvals according to the Medical Device Regulation (MDR) and the Food and Drug Administration (FDA), cybersecurity requirements for healthcare facilities, and standard-compliant development processes according to the IEC 62304 standard place high demands on manufacturers and operators alike.
sepp.med supports medtech companies and healthcare facilities in meeting these challenges. With over 40 years of experience in software development and quality assurance for regulated industries, we provide comprehensive consulting services, including process consulting, software validation, cybersecurity, and support for market entry in Germany.
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