VISAMED Consulting Services for Medical Industries

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

Send mail to info@visa-med.com with questions or comments about this web site.