I have found that NJK & Associates delivers hands-on comprehensive regulatory services associated with medical products and, with their collective experience and intellectual horsepower, they are an ideal fit with our company when we need regulatory and quality systems guidance in our diverse medical product development environment. They have the added benefit of experience in design engineering and production engineering and are a quick study when briefing them on technologies under development. As a result, they present sound strategies for practical solutions to compliance activity while sensitive to company culture.
NJK can help navigate the regulatory pathways and set up Quality Systems for startup medical device companies and I have also seen them rescue large companies who are faced with unexpected post-market challenges. They are my “go-to” resource and I can depend on them for their seasoned experience when I’m grappling with regulatory issues that apply to unique or novel technologies when developing medical products that are headed toward a 510(k) Premarket or PMA submission to the FDA.