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Quality Management System Development and Standards Compliance
Class I Medical Device, General IVD or Class A IVD Self Certification CE Marking
Class I Software as a Medical Device (SaMD)/General In Vitro Diagnostics (IVD) SaMD Quality Management System (QMS)
Class IIa/b/Non-General/Class B, Class C or Class D IVD Self Certification CE Marking
Combined Class I SaMD/Physical Medical Device QMS
Combined Class IIa/IIb SaMD/Physical Medical Device QMS
DCB0129 Clinical Safety Management System (CSMS)
Information Security Management System (ISMS)
Physical Medical Device (Class I/General IVD) QMS
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