- Solution
Overview - IEC 62304
Compliance - FDA 21 CFR Part 820
Compliance - FDA 21 CFR Part 11
Compliance
FDA 21 CFR Part 820 Compliance
Quality Management System for the entire medical product lifecycle
- Need to adhere to FDA´s Quality Systems Regulation Requirements
- Must achieve FDA 21 CFR Part 820 compliance quicker
- Budget restrictions due to funding being dependent on FDA compliance
- QA-Team and testers have never worked with FDA 21 CFR Part 820
- Components from many different suppliers make maintenance of
Design Controls and Design Documents a nightmare
Traditionally, to achieve FDA 21 CFR Part 820 compliance you would labor through mountains of paper documents, tons of disparate digital documents or invest the majority of your budget in costly Document Management Systems. With Polarion ALM you enjoy a requirements-based lifecycle management. In minutes you create a Document History File (DHS) at any point in time – including forensic level traceability to satisfy any audit. Save up to 80 per cent costs in record keeping, risk management and audits. Implement our solution in light speed – usually less than eight to ten days.
Key Benefits
- Achieve FDA 21 CFR Part 820 compliance quicker
- Reduce costs involved to comply with FDA regulations
- Maintain complete audit trail records
- Increase end user acceptance and productivity by employing an industry-proven, seamlessly integrated solution
- Provides out-of-the-box templates and processes to use or modify
- Communicate quality issues 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:
