Governance & Compliance

 

Governance & Compliance

esagoni

 

 

Mission

  • Our mission is to provide consultancy to help Customers in the development and procurement of products conforming to international standards (IEC / EN, ANSI / IEEE, ISO, CMMI).
  • We support customers in developing a strategy for the safety and compliance of products by managing the changes resulting from the new standards or new editions of standards.

Areas

The Governance & Compliance practice provides the following services:

  • Product Compliance related to reach the product certification (CE marking or successful assessment) to allow Customers to homologate/commission the product
  • Process Compliance/Governance to help Customers to set up the organization necessary to manage technical standards or best practices (ISO IEC 15504 –Spice , A-SPICE, CMMI, ITIL, etc.) related to quality, safety, security, software, hardware issues.
  • Reverse Compliance to help Customers to reach compliance for existing products
  • Training services related to the need of Customers to get compliance and work in compliance

Services

  • Adoption and implementation of technical standards/models and relevant updates (e.g. EN 50128: 2011, ISO 26262, ISO 27001, CMMI)
  • Preparation of RAM plans and Safety Plans and related RAMS analysis to support reliability/availability demonstration and system/device maintainability
  • Preparation of Safety Cases accordingly to Functional Safety directives IEC 61508, EN 50128/6/9 (Transportation), RTCA/DO 178B and DO 254 directives
  • Definition of processes not fully standardized (e.g. Programmable Devices)
  • Support for incoming audits and/or supplier audits
  • Training on standards, maturity models, techniques and tools
  • Development, verification and validation of software and hardware products in accordance with the applicable standards
  • Reverse compliance projects in which the product is given but the documentation must be prepared in compliance with applicable norms
  • Qualification of tools and facilities (e.g. compilers in accordance with regulatory requirements).
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Compliance for Automotive flyer

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AIDA Model

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Compliance for Med Devices flyer

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Auto Training Services flyer

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Compliance for Railways flyer

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Compliance for Pharma flyer