Validation

Medical device manufacturers are required to adhere to strict guidelines when it comes to validating their equipment and processes. At DesignPro Automation, we have a dedicated team of experts who support the creation of clear, accessible technical documentation for the design, test and build of our advanced automated solutions. Our engineers have successfully integrated systems into highly regulated environments such as; ISO Class 8 production.

All machines come with an extensive list of documentation

• Operation Manual
• Bills of Materials
• Mechanical Drawings
• Electrical Drawings
• CE Certification
• Pneumatics Drawings
• Standard Parts Info
• Functional Design Specification (FDS)
• Software Design Specification (SDS)
• Product Contact Material Report