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).

The Software Validation Superpack includes two critical tools:

  1. A detailed and comprehensive checklist to help you identify gaps against IEC 62304.
  2. 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.
SKU: SP-SV Category: