What is the MOST appropriate action for improving product life cycle management of medical devices?

Choosing to identify countries where specific requirements exist during the product development phase is the most appropriate action for improving product life cycle management of medical devices. This approach ensures that the regulatory landscape is taken into account from the very beginning of the product development process. By understanding the specific requirements of different jurisdictions ahead of time, a company can streamline its submission process and avoid delays later in the life cycle due to unforeseen regulatory hurdles.

Considering various market regulations during the product development phase allows for better strategic planning and may lead to the design of products that comply with international standards, thereby facilitating smoother market entry in multiple regions. This proactive strategy can help prioritize resources effectively and align product features with regulatory expectations, which ultimately supports a more efficient and successful product life cycle management strategy.

While utilizing the STED template and planning regulatory meetings are important steps, they are more tactical and do not address foundational strategic alignment early in the process. Initiating a global submission process only after design elements are finalized misses the opportunity to integrate regulatory considerations throughout the development, which can result in increased costs and delayed product launches.