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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.

[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_empty_space][sc_heading size=”0″ align=”center”]Our Software Testing Process[/sc_heading][vc_single_image image=”5106″ img_size=”large” alignment=”center”][vc_column_text]

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:

  • software V&V plan
  • test protocols
  • test reports
  • all supporting evidence additional documents to complete your technical file

[/vc_column_text][sc_heading size=”0″ align=”center”]Why Us?[/sc_heading][vc_row_inner][vc_column_inner width=”1/3″][vc_column_text]

Server located in an certified datacenter in Germany –compliant to the (FDPA) in Germany, and (GDPR) in the EU

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ISO13485:2016 compliant Quality Management System

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FDA CFR Part 11 and the Quality System Regulations, Computer System Validation (CSV)

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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

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ISO13485:2016 compliant Quality Management System

[/vc_column_text][sc_button link=”http://www.access2hc.com/outsourced-software-verification-and-validation-enquiry-form.html” target=”1″ style=”1″ color=”#dd8500″]Remote Software V&V Enquiry Form[/sc_button][vc_empty_space][vc_column_text]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[/vc_column_text][sc_button link=”http://www.access2hc.com/outsourced-software-verification-and-validation-enquiry-form.html” target=”1″ style=”1″ color=”#dd9221″]Remote Software V&V Enquiry Form[/sc_button][/vc_column][/vc_row][vc_row content_placement=”middle” leaf_row_scheme=”0″][vc_column width=”1/4″][vc_row_inner][vc_column_inner width=”1/2″][vc_single_image image=”6069″ img_size=”full” alignment=”center” onclick=”custom_link” css=”.vc_custom_1596292625862{margin-bottom: 10px !important;}” link=”http://access2hc.com/business-development/”][vc_column_text]

Business Model Development

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Engineering Conceptualisation

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Medical Technology Design & Development

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Quality Systems Consulting

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Go-To-Market Strategy Services

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Full Suite Regulatory Services

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Business Due Diligence

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Regional Sales / Tech Service Hub

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