Safety-related Systems & Embedded Architectures
Emdesar offers consulting and coaching services in the field of product development of safety-critical systems. The strength of Emdesar is the broad experience from different areas, which enables applying best practices across domain boundaries.
Selection of consulting and coaching services:
- Risk-based HW/SW architecture development
- Attaining single-fault safety acc. to IEC 60601-1 by design
- Avoiding SW/HW related hazards acc. to IEC/TR 80002-1
- Applying HW/SW risk management acc. to ISO 14971
- Tool environments for compliant Medical Device development
- Process elaboration for Medical Devices development
- Independent reviews of HW/SW architectures & designs
- Coaching of HW/SW development teams
- Functional Safety training
Selection of standards:
- IEC 61508, EN 50126/28/29/59, IEC 61800-5-2
- IEC 60601-1, IEC 62304/82304, IEC/TR 80002-1, IEC 62366-1
- IEC 62443-4, IEC 81001-5-1 (Medical Device Cyber Security)
- Various FDA guidelines & MDR related documents
Contact:
https://www.linkedin.com/in/felix-kessler-el-ing-eth/
Emdesar GmbH
Grubenstrasse 9
CH-4142 Münchenstein
Switzerland
info@emdesar.ch
+41 79 592 55 28
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