Documentation, Validation and Compliance Support
At SAVASTO, our catheter manufacturing machines comply with relevant requirements, and are shipped with complete documentation. Quality and safety are driving principles in the design and manufacture of our Catheter manufacturing machines and systems.
All of our machines are shipped with complete standard documentation to ensure that you are able to find all information and paperwork you may need to solve any technical problems or service issues that may occur.
Documentation
All SAVASTO catheter manufacturing machines come with standardized documentation:
SAVASTO provides detailed documentation for all machines, and the documentation package is sufficient to meet all client compliance needs. All customers receive a duplicate printed copy of the documentation as well as an electronic copy. Additional digital copies are available through the customer service portal
The Documentation Pack Includes The Following:
Operating manual with troubleshooting guide
Software development plan, software configuration management plan, software requirement specifications, software design document, and software functional test.
We can participate in the IQ template development and assist with IQ, OG, PQ process
Quality Capabilities
As medical catheter devices and get more complex, manufacturing is still required to be the highest quality and be easy to use for operators. Our catheter manufacturing machines produce reliable, easy to manufacture products.
SAVASTO Quality professionals have extensive knowledge in the application of standards across medical device manufacturing, and we have broad experience in medical device manufacturing machine and system design including design control and design assurance for medical devices manufacturing machinery.
Contact Us
Interested in our catheter manufacturing machines? Fill in the form below and we will get in touch with you.