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R&D Support
Time to market, quality to market and cost to market are the three main areas where medical devices companies are focusing. For a cost effective and short product development program, it is important to properly design the development activities and identify the critical milestones as early as possible. Furthermore, the R&D operations should be organized in a manner that allows flexibility to operate effectively while at the same time maintaining compliance with quality systems and regulatory requirements. VISAMED can assist you in the following activities:
 Establish an R/D quality system (Design control process) that complies to US FDA Quality Systems
Requirements (QSR) and to European and Canadian quality standards ISO 13485
R/D projects planning: tasks, resource allocation using established and automated project
management techniques
Support the design verification and validation activities including assistance in the development
test strategies, test plans, test reports to fulfill regulatory requirements and standards
Literature and market research to support bench mark studies
Biocompatibility testing strategy and coordination
Coordinate Packaging and sterilization testing
Establish and maintain design history file
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Tel. +49(0)721-4764847