|Our Mission 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.|
MAK and Associates, LLC was founded in 2009 by Steve Krueger to provide quality and regulatory services to medical device companies. With his background in software development, Steve struggled to understand the complex procedures within a product development cycle while working for a major medical device company. He remembers, “Our paperwork required for a product release had to be reviewed and was scrutinized by the company’s quality and regulatory department often the project file stack was returned with many yellow post it notes marking disapproval.” Based on his compliance experiences working for several medical device companies, Steve saw an unmet need to provide basic support to his peers who were struggling to implement a regulated quality system, finish a product submission to the FDA, or survive an ISO audit or FDA inspection. Fundamental to a regulated company’s success is getting its products to market quickly and sustaining a balance with product quality and regulatory compliance. This simple concept was applied while helping several medical device start-ups strike a compliance balance based on risks and Steve’s understanding of the regulatory authorities expectations. MAK’s success has grown because of partnerships with other industry experts called in to solve client issues and problems in a professional manner.
In 2012, the MAK Biotechnology Consulting Consortium (BCC) to further enable a group of like minded entrepreneurs a system to share work and resources. The original BCC members met to encourage and provide feedback on each other’s business operations. It was a non threatening environment to try out new ideas or ask for someone’s opinion on a tough problem. BCC members were able to collaborate on projects and further enhance knowledge in unmet areas.
In 2014, a sustainable business model was developed as a result of the MAK BCC and is being brought forward in the MAK Compliance Minds online community. Alongside the MAK consulting services, compliance minds was developed to provide a place for people to find answers, get help, and learn about regulatory compliance in the life science industries.