2 laboratories in Germany are accredited by A2LA under ISO/IEC 17025 to perform IEC 62304 testing. From the accredited scope text: “IEC 62304; IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION; ANSI AAMI IEC 62304; ANSI AAMI IEC 62304:2006/A1:2016; CSA CEI/IEC 62304; EN 62304 IEC 62366-1; IEC 62366-1 Edition 1.1 2020-06 CONSOLIDA” “IEC 62304:2006 + A1:2015 EN 62304:2006 + A1:2015 DIN EN 62304: 2016 VDE 0750-101:2016 Medical Device soLware - SoLware life cycle processes. A Product Safety IEC 62366:2007 EN 62366:2008 DIN EN 62366:”
Only 2 labs match this combination. Try broader options below.
See all accredited labs in Germany or browse other methods such as EN ISO 9001, EN ISO 10523, EN ISO 19458.
China, DE
IEC 62304; IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION; ANSI AAMI IEC 62304; ANSI AAMI IEC 62304:2006/A1:2016; CSA CEI/IEC 62304; EN 62304 IEC 62366-1; IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION; ANSI AAMI IEC 6236
Japan, DE
IEC 62304:2006 + A1:2015 EN 62304:2006 + A1:2015 DIN EN 62304: 2016 VDE 0750-101:2016 Medical Device soLware - SoLware life cycle processes. A Product Safety IEC 62366:2007 EN 62366:2008 DIN EN 62366:2008 VDE 0750-241
This page is a fixed slice of the register: every IEC 62304 scope we hold for Germany. Search narrows it further by city, accreditation body, or a term from the scope text itself.
Search labs in GermanyAmerican Association for Laboratory Accreditation (A2LA) is the primary accreditation body issuing ISO/IEC 17025 accreditation for testing laboratories in Germany.
ISO/IEC 17025 is the international standard for the competence of testing and calibration laboratories. Accreditation to this standard provides independent confirmation that a laboratory operates a quality management system and is technically competent to produce valid results within its declared scope.