No one understands your product as well as you. Your regulatory partner will learn about it, care about its mission, and help you present it to a regulatory audience. There are few decisions as big as bringing a medical device to the market. The regulatory strategy is heavily intertwined with the overall business strategy. A strong partnership between your firm’s executives, product managers, engineers, and regulatory experts is essential to find the optimum regulatory pathway.
Your regulatory and business strategy will be carried out during the dynamic execution phase. Your regulatory partner will guide and advise your team. As product development continues, interactions with regulators begin. New issues invariably arise, such as design changes that affect the regulatory approach and vice versa. During this phase, design documentation is created, much of which supports communications with the regulators.
Your hard work pays off when you receive regulatory permission to market the product and transfer it into the production phase. Your regulatory partners continue to be key contributors to your success. Good manufacturing processes must be routine, efficient, and effective. Post-market regulatory activities start in earnest. Customer complaints and regulatory reporting are handled in a timely and professional manner. Design changes require regulatory review and, in some instances, trigger submissions to the regulatory agencies.
Peter takes an inventive approach to regulatory leadership, leveraging his own knowledge and experience with regulations and agencies, and the deep technical expertise of the designers, to present medical devices in a manner that ensures they are on an effective path to market access and compliance.
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