In this episode, host Brandon Miller is joined by Jessica Schafersman, a Biomedical Engineer, Project Management Professional, and Certified Usability Analyst at Regulatory Compliance Associates® (RCA). Together, they delve into the critical topic of design controls and the proper approach to developing your Design History File (DHF) for medical device products.
Jessica begins by discussing the current trends consultants are observing in the industry. She highlights the growing importance of meticulous design controls and the role they play in ensuring the safety and efficacy of medical devices. By understanding these trends, manufacturers can better navigate the complex regulatory landscape and avoid common pitfalls.
The conversation then shifts to the invaluable support that experts can provide throughout the DHF development process. Jessica explains how professionals like herself can guide companies in establishing robust design controls, ensuring that all necessary documentation is in place and that the product development process is compliant with regulatory standards.
Listeners will gain insights into the first steps of obtaining the right help for DHF development. Jessica outlines practical steps for engaging with consultants and leveraging their expertise to streamline the process. She also shares advice on what to look for in a consulting partner and how to build a collaborative relationship that enhances the overall quality of the DHF.
The episode concludes with a discussion of the major pitfalls clients often face during the DHF process. Jessica provides real-world examples and lessons learned from past projects, offering actionable tips to help listeners avoid these common mistakes and ensure a smooth and successful DHF development.
This episode is essential for medical device professionals involved in design controls, regulatory compliance, and quality assurance. By tuning in, you will learn how to effectively develop and manage your DHF, ensuring your products meet the highest standards of safety and regulatory compliance.