Software defects have been pointed as the primary cause for many product recalls in the past years. Software verification and validation is a critical component of product development, yet some companies just don’t have the right tools or resources for appropriate software testing. You can’t test your own code!
Access-2-Healthcare provides this much-needed service for all medical technology / medical device companies around the world to ease the pain of limited resources for software testing.
Access-2-Healthcare:
– Perform test scripts writing according to the set requirements and specifications
– Perform QA check on your validation and verification protocols
– Execute tests according to your approved test protocols, complete with all documentation
– Ensure 100% compliance to ISO13485 and IEC62304
– Ensure all of the documentation are complete and readily available for:
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software V&V plan
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test protocols
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test reports
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all supporting evidence additional documents to complete your technical file
Server located in an certified datacenter in Germany –compliant to the (FDPA) in Germany, and (GDPR) in the EU
ISO13485:2016 compliant Quality Management System
FDA CFR Part 11 and the Quality System Regulations, Computer System Validation (CSV)
All our expert software testers communicate through the encrypted gateway and the server is disconnected from the Internet.
If you’d like to understand more, please click the box to complete our enquiry form
ISO13485:2016 compliant Quality Management System
All our expert software testers communicate through the encrypted gateway and the server is disconnected from the Internet.
If you’d like to understand more, please click the box to complete our enquiry form
