The development of medical device, hardware and software is strongly linked to risk management and compliance with safety requirements according to international standards. Whether you need consultancy, support or training – Lorit Consultancy supports your team with its extensive international expertise in safe product design, hardware and software development. International standards we work with: ISO 14971, IEC 60601, IEC 62366, IEC 62304, AAMI TIR57
Services:Risk management Requirements management Quality management Hardware and embedded software reviews Product architecture Failure mode and effect analysis (FMEA), fault tree analysis (FTA), failure mode and effect analysis (FMECA), hazard and operability (HAZOP) Preparation of all relevant work packages, reviews and reports Cybersecurity and usability Reliability engineering ISO 14971, IEC 60601, IEC 62366, IEC 62304, AAMI TIR57 Bespoke training courses
Siezenheimer Str. 35
5020 Salzburg
Salzburg
Contact: Alastair Walker (CEO)
Email: info@lorit-consultancy.com
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