Software QMS SOPs & Templates

This starter-pack of Software QMS procedures and templates is essential if you are developing software as part of a medical device or in health software. It includes 8 documents that will supplement your general QMS documents. These focus on IEC 62304 requirements including draft IEC 62304 ED2 requirements. Note: IEC 62304 CD2 is yet to be finalised so, come back in a year or two when the final version is released for an update. If you bought the original pack, you will get supplements at a significantly reduced price. Nevertheless, you need to be aware of the potential changes, so download today.

This pack includes:

• Software Quality Policy
• Software Development Lifecycle SOP
• Risk Management SOP (software focus)
• Supplier Third Party Management SOP
• Usability Engineering (software focus)
• Software Verification and Validation SOP
• Risk Management Plan & File Template
• Software Release Checklist