Code Refinery's expertise in FDA compliance for software contained in medical devices is central to the services we offer our clients. We help you decrease your time to market without sacrificing quality and establish a high-level of confidence in your product.
Regulatory requirements and mandates are increasingly stringent for manufacturers of medical devices as well as regulated products and systems. Many times, a company’s success depends on its ability to move through the regulatory process smoothly and efficiently to get its product to market, while ensuring a high level of compliance and quality.
We understand the intent of FDA regulations to ensure software safety, quality and efficacy, which why we tailor a solution that will adequately and efficiently meet these objectives.
Quality System Assessment
Code Refinery’s team can audit your existing Quality System to make sure the proper procedures exist for development of your software product. We can also provide recommendations and implement the procedures which integrate with your organization and your current processes.
Software Development Life Cycle
Code Refinery can help you design and implement a development life cycle for your medical device software to make sure it complies with current Quality System Regulations.
Software Documentation for FDA Device Submissions
Code Refinery can augment your team by developing software documentation for your FDA device submission package. Our experts can analyze your current documentation detail and develop the necessary software sections for a 510(K) or PMA.
Services
- Code Refinery recognizes the challenges of developing...
FDA Compliance
- Code Refinery's expertise in FDA compliance for software...
Custom Software
- At Code Refinery, we place great emphasis on clearly understanding your problem...
Verification and Validation
- The concepts of system verification, validation and qualification are not new; however, ...
Development Process
- See how we evaluate and address the most intricate challenges...
