Healthcare / Life Sciences



PASS Services for the Healthcare & Life Sciences Industry

Ensuring product quality and compliance throughout the entire product lifecycle is a constant challenge, requiring expert knowledge and dynamic scalability of specific skills and testing resources. PASS is your reliable and cost-efficient partner for taking care of the entire spectrum of functions and responsibilities in System Integration, Quality Assurance and Verification&Validation for Medical Devices and Software.

 System Integration Verification & Validation Consulting
System Integration Verification and Validation Consulting
  • Hardware
  • Software
  • Applications
  • Software-/System Module & Integration Tests
  • Software-/System Verification & Validation
  • Project Assessments
  • Project Management
  • V&V Management

 

PASS provides  expertise specializing in areas under very strict regulatory controls, conforming with european and US regulations such as 21 CFR 820 and 21 CFR part 11, Medical Device Directive 93/42/EEC and In-Vitro Diagnostics Directive 98/79CE.


V&V Consulting

Organisation & Strategy
Methods & Processes
Compliance, Risk and Safety
ISO 13485, 62304, 14971
21 CFR part 820 & part 11
IVD 98/79CE
MDD 93/42/EEC


V&V Services

Management of complete V&V Projects
Test Management
Documentation Concepts
DHF Management
Reliability Testing & Growth Monitoring
Test Tools Evaluation
Hardware, Software & System Test



Use PASS expertise and resources to ensure success of your system development project!


Association Memberships

PASS is an active member of Toolpoint for Life Science association, the swiss industry cluster of leading suppliers of equipment and services to the life science industry.

PASS is a supporting member of the SiLA consortium for Standardisation in Lab Automation, an organisation of instrumentation-, software- and integration services suppliers to the life science lab automation industry and leading pharma and biotech corporations.

 

 

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