Code Refinery
e: sdandekar@code-refinery.com
v: 1.919.367.0003
Code Refinery gives medical device companies complete confidence in their product’s software, and peace of mind that it will meet the highest standards for FDA compliance and real-world operation. From the challenging and complex FDA approval process to hospital and lab applications, medical device companies can’t afford to be less than 100% certain about the software. Human lives are at stake. Code Refinery understands the challenge and the software regulatory process very well and our successful implementations prove that. We have developed a robust engagement process to evaluate and address the toughest and most intricate challenges, and implement solutions that keep us aligned with our clients. We are thorough and efficient with every one of our FDA-compliant software quality assurance projects and our clients can count on their devices operating to the highest standards.
When it has to be right, you can count on Code Refinery. Compliance without compromise.
Mike Brown, Partner, Director of Operations
For the past 15 years, Mr. Brown’s has designed and developed electromechanical systems used in spacecraft, lab and medical instrumentation. He has developed systems for uses ranging from NASA research rockets to highly complex medical devices. Mr. Brown manages Code Refinery’s operations and the software testing and validation team.
Samir Dandekar, Partner, Director of Business Development
Mr. Dandekar has 15 years of experience in the development and validation of laboratory automation systems and medical devices. Mr. Dandekar is responsible for Code Refinery’s strategic and business development. His technical responsibilities include project management, and software development and documentation.
Greg Godlevski, Partner, Director of Software & Information Technology
Mr. Godlevski has 20 years of software development experience in medical device and FDA-regulated industries, and in managing the development and commercialization of software and hardware for medical instrumentation and systems. He is an expert in software development for the life sciences including validation, Quality System Regulations, and 21 CFR Part 11 issues. Mr. Godlevski has authored a software development methodology that has been successfully reviewed by FDA and ISO auditors.
