Code Refinery What we offer




















Regulatory Compliance

Regulatory requirements and mandates are increasingly stringent for manufacturers of medical devices and other quality controlled 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.

Code Refinery's expertise in FDA compliance for software contained in medical devices is core to what 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.

We guide you through the compliance process by providing regulatory risk assessment, formal documentation, validation and verification, and submission services.

From device submissions to Quality System assessments, you can rely on Code Refinery’s experience and proven track record. We understand the intent of FDA regulations to ensure software safety, quality and efficacy, and we make sure you adequately meet these objectives.



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