We are a passionate and dedicated consulting group that offers a flexible approach to solving your dilemmas. By taking into consideration our experience, successes, and failures we have the knowledge to put you on the correct path. We consider ourselves experts in FDA and ISO regulations and medical technology software. For over 30 years we have developed, assessed, tested and qualified software. We pride ourselves on deep knowledge of software, regulatory, risk management, validation, and 21 CFR consultation for medical device, technology, and IVD manufacturers. Our approach is to focus on the client’s organizational maturity and business goals to provide an effective risk-based solution without sacrificing device safety and/or efficacy We strike at the core issues quickly and save you time, effort, and money. We use a flexible-situational approach – we seek first to understand our clients’ people, processes, and products and come up with a solution for your organization’s culture. Our support can range from strategic advice on the regulatory classification to full hands-on remediation of any quality system documentation or records.