Software Validation Superpack
Enabling rapid compliance with EU and US requirements for Medical Device Software!
Validating medical device software can be challenging, especially when the software is a component part of or is embedded within a more complex medical device. Not only is it necessary to develop and test the software, but it must be validated in accordance with regulatory expectations, often with reference to the broader medical device.
In addition, more and more regulators are now mandating that connected medical devices be protected against cyber threats. This superpack gives you all the tools you need to get your medical device software approved in EU and US – quickly.
Note: This superpack does not include any tools for validation of non-medical device software (e.g. Document Control software, Manufacturing software, LIMS, Calibration software, Complaint Handling software, ERP software, CRM software).
- A detailed and comprehensive checklist to help you identify gaps against IEC 62304.
- A detailed and comprehensive procedure to help you comply with IEC 62304, FDA Guidance on Software Validation, UL 2900-1 and UL 2900-2-1.
In addition, it includes twelve templates to help you quickly generate supporting records:
- Design and Development Template
- Architecture and Detailed Design Specifications Template
- System Requirements Template
- Unit Test Protocol
- Unit Test Report
- Integration Test Protocol
- Integration Test Report
- System Test Protocol
- System Test Report
- Cybersecurity Requirements Form
- Cybersecurity Test Form
- Product Use Documentation Form