Whether you are planning your first product launch or expanding from Asia into the United States, your passion for your business demands seasoned professionals who can guide you and your company through the maze of regulations and quality requirements for medical device and IVD products.
Vision28 provides pragmatic medical device and IVD consulting for Quality and Regulatory services to medical device industries, including FDA, Medical Device Directive (MDD), Japan PMDA, or Health Canada.
We provide comprehensive Regulatory and Quality services, including 510(k) writing; Preliminary Regulatory Analyses; Regulatory Strategy development; Auditing, Improving or Installing quality systems; and Software, Product and Process Validation.
We are known for our pragmatic, efficient and LEAN approach to all of your Quality and Regulatory projects. We don’t just give you broad advice, we give you specific, actionable advice and then execute upon your approval to move your business forward.