PURTEX s.r.o.

MAK and Associates is a regulatory compliance and quality consulting firm specializing in medical device regulatory support. Led by Steve Krueger, a computer engineer and Six Sigma Black Belt with 20+ years of medical device industry experience, the firm provides expert guidance in FDA compliance, verification and validation, quality systems development, post-market surveillance, adverse event reporting, and regulatory submissions. Services include US FDA Agent representation for international medical device companies, compliance monitoring programs, and risk-based testing strategies. The firm serves medical device startups and established manufacturers navigating FDA, MDR, and ISO requirements to accelerate market entry and ensure regulatory compliance.