- Solution
Overview - IEC 62304
Compliance - FDA 21 CFR Part 820
Compliance - FDA 21 CFR Part 11
Compliance
IEC 62304 Compliance
- Must achieve IEC 62304 compliance quicker
- Audit-related reports must be created faster to meet auditors requirements
- Implemented processes, actions and approvals must be proven
and tracked at a forensic levelduring the entire lifecycle - All upcoming risks must be collected and mitigated properly
- Reports must be based on all relevant information and published
auditor-ready-style
The IEC 62304 standard specifies lifecycle requirements for the development of software within medical devices in means of implementing a Quality Management System. Traditionally, to achieve this kind of system you would have to manage gazillions of disparate documents in paper or digital format or invest a huge part of your budget in costly point solutions to manage your documents and processes. With Polarion ALM you enjoy a requirements-based lifecycle management – compliance with IEC 62304 included. In minutes you create any reports at any point in time - including forensic level traceability to satisfy any audit. And the solution can be implemented in light speed – usually less than eight to ten days.
Key Benefits
- Achieve proven IEC 62304 compliance through complete tracking (historic) record
- Reduce costs involved to comply with IEC 62304 regulations
- Maintain complete audit trail records
- Increase end user acceptance and productivity by employing an industry-proven,
seamlessly integrated solution - Communicating quality issues made easy by monitoring and reporting defects
and managing product complaints and adverse events - Eliminate rework and maximize re-use
Download FREE Documents
Polarion FDA 21 CFR Part 820
Full Compliance
Polarion FDA 21 CFR Part 11
Full Compliance
Polarion Medical Device
Solution White Papers pack
"Polarion provides the complete Infrastructure. All important components like Configuration Management, Traceability, Process support, Documentation and Checklists are not only available they are all pre-configured and integrated.
Our Customers
Here are a few examples of our customers in the Medical Devices, Biotechnology and Pharmaceuticals sectors:
