MAK and Associates, LLC Logo - medical devices

MAK and Associates, LLC

medical devices
China's Best One-Stop Medical Equipment Provider
About

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.

Technologies
Gmail Blue Host Google Apps Apache Google Font API Mobile Friendly Bootstrap Framework WordPress.org Remote Android AI
Keywords
hipaa fda gmp regulatory submissions regulatory compliance medical equipment manufacturing regulatory audit support u.s. fda agent regulatory consulting risk-based testing adverse event reporting compliance consulting medical equipment and supplies manufacturing adverse event management corrective actions clinical data support u.s. market entry b2b product safety verification and validation international medical device regulation support product development support healthcare quality systems trend analysis in post-market surveillance quality management system medical device recalls iso 13485 product development fda regulations global regulatory support
Company Information
  • Employees 6
  • Founded 2009
  • Annual Revenue $5906000
Location

13455 Bobby Ln, Elm Grove, Wisconsin, United States, 53122-1315

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