Albert Klaas

Compliance control for medical device software development processes. Objectives are intended use/user needs documentation, design input requirements, software risk assessment, risk related design input, design output, design output verification, traceability, product validation against intended use/user needs. Applying standards are IEC 62304, ISO 14971, TR 80002-1, IEC 62366, Audit Experience: internal audits, TÜV and BSI Certification Audits for 13485, MDSAPs

Test engineering, raise and maintenance of the company's quality management system (handbook, procedures, work instructions), design control for medical device software, project documentation, internal audits, management reviews, CAPA management, complaint handling, quality management representative.

Atomphysik, Ionenfallen