MAK and Associates, LLC empowers medical device startups accelerate their journey from concept to market by providing expert guidance in regulatory compliance, quality systems, and product development. We specialize in navigating FDA, MDR, and ISO requirements, ensuring early-stage companies avoid costly pitfalls and achieve rapid approval. With a hands-on approach tailored to emerging innovators, we streamline the path to commercialization, empowering startups to bring groundbreaking medical technologies to patients faster and with confidence.