Whether you are planning your first product launch or expanding from Asia or Europe into the United States, your passion for your business demands seasoned professionals with decades of experience in quality and regulatory, who can develop quality and regulatory strategies to guide you and your company through the maze of regulations and quality requirements for medical device and IVD products. In addition to guidance, we know how to “roll up our sleeves” and go to work for you on a very hands on and practical basis.
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, and Health Canada.
We provide comprehensive Regulatory and Quality services, including 510(k) writing; Preliminary Regulatory Analyses; regulatory strategy development; response to FDA-483 observations; auditing; improving or installing quality systems; Software as a Medical Device; 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 we “roll up our sleeves” to move your business forward.