Code Refinery is an ISO 9001 and ISO 13485 registered firm and our quality system and processes meet FDA CFR 820 regulations.
Custom Software Development
Code Refinery develops custom FDA-compliant medical device software used in:
- Blood screening systems
- Patient monitoring equipment
- Computer-controlled surgical instruments
- Automated laboratories
- Pharmaceutical research instrumentation
- Point-of-care (POC) analysis tools
We deliver software that is fully documented, completely tested, and expertly verified. For a more comprehensive look at our software development life cycle, visit Our Process.
Software Verification and Validation
With our in-depth knowledge of the regulatory process, we customize a testing approach to match your specific application requirements and the relative risk of the software involved. We demonstrate the software’s consistency, completeness and accuracy at each stage of the development life cycle, assuring safety and effectiveness and improving process efficiency to meet FDA regulations.
Quality Systems and Regulatory Consulting
A company’s success often depends upon its ability to move a product through the regulatory process smoothly and efficiently, while ensuring a high level of compliance and quality. Code Refinery will help you decrease your time to market without sacrificing quality.
Quality System Assessment
Code Refinery will audit your existing quality system to make sure the proper procedures exist for the development of your software product. We will also provide recommendations and implement the procedures that will integrate with your organization and your current processes.
Launch Readiness Review
Code Refinery will quickly assess your software and determine if it’s FDA binder-ready for approval. The FDA has 90 days to respond after they receive a medical device submission and addressing issues early can help you avoid costly delays later.
- Windows 7, 8, 8.1, 10
- Windows Embedded
- C#, C++, C
- SQL Server
- Visual Basic
- Unit Testing
- Ad Hoc Testing
- Verification Testing
- Validation Testing
Software Engineering Tools
- Enterprise Architect
- Seapine Requirements Management
- Seapine TestTrack Pro
- Sourcegear Vault Version Control
- Team Foundation Server