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.

Our experienced team can help you tailor these to your device and organisation, contact us at: www.stjohnlynch.com

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