MAK and Associates, LLC

MAK and Associates is a group of successful regulatory, quality, and engineering professionals. We have solved many regulatory compliance problems applying our expertise, resources, and tool sets. We will put your anxiety to rest.

We provide high service quality, uniqueness and value to our customers based on a hard work ethic, small-scale operations, frugality and austerity, and a use of highly trained and experienced subject matter experts.

Steve Krueger is owner and principal consultant of MAK and Associates based in Milwaukee, Wisconsin. With over 20 years of experience; he is an expert in the verification, validation, and post market surveillance of medical devices. Steve is formally trained as a computer engineer, six sigma black belt, and technical manager. He has held several medical device industry positions as a software engineer, systems integration engineer, quality engineer, verification and validation leader, service engineering leader, and quality/regulatory leader for small startups to fortune 100 companies. Steve has led many product test efforts through the development of practical plans, risk based management, and execution. Steve has taught risk-based verification and shares his common sense experience among his customers and peers.

Company’s Keywords:

regulatory compliance, regulatory submissions, fda gmp, hipaa