Medical Compliance
Modern, Easy, on any Device

Medical Compliance Software on Microsoft 365

The need to comply with the international standard ISO13485 requirements, Medical Device Regulations (MDR) and FDA is challenging for managers in all medical device related industries and healthcare sectors.

BPAMedical365® is an innovative software for medical quality & compliance management, ready to use in your trusted Microsoft 365 environment, including the main modules of our Quality Management QMS software plus additional modules for eSignature and product lifecycle management.

O365
SP2013/2016/2019

Satisfy GxP Guidelines with Microsoft 365

Microsoft Office 365 includes solid features to satisfy GxP guidelines and 21 CFR Part 11 requirements for electronic records, like document retention, access control, and audit trail. Our eSignature module gives the extra security required when approving items.

The app provides a robust collaborative platform for the whole organization, leveraging SharePoint and Teams capabilities for instant discussions and video conferencing. Go a step further and meet Industry 4.0 objectives with the Audit Power Apps, Incident and Failure Catalogue Power Apps, and prebuilt automated workflows.

Simplify Your Journey to ISO 13485

We provide an ISO 13485 documentation kit, ready to be imported in BPAMedical365®, which include 140+ document templates to facilitate your journey to comply with ISO 13485.

Our software validation quick start package simplifies software (SW) validation, and includes document templates, like a SW validation plan, SW validation SOP, requirement specifications, and test case samples for BPAMedical365®.