Regulatory & Quality Controls/ Quality Assurance

Recorded sessions on the topic of regulatory strategy guides innovators—especially entrepreneurs new to the medical device space—through the critical considerations in choosing a regulatory pathway. Participants will gain insight into key regulatory requirements, pathways, and decision points essential for bringing medical devices to market. Ideal for those who want to understand how regulation intersects with product development from the earliest stages.

YouTube playlist covers essential aspects of medical device regulation, clinical trials, and FDA compliance, providing a comprehensive guide to navigating regulatory waters for innovators and stakeholders in healthcare innovation. Topics covered include: Target Product Profile, Regulatory and Clinical Trials for Therapeutics, FDA Regulation Series (3 parts), and a Case Study: AlertWatch and FDA 510(k).

Repository of links from government, academic, and scientific institutions, providing an overview of regulatory information along with resources to help orient clinical research professionals in their approach to plan and conduct clinical trials in the United States, ultimately bringing bench discoveries to the patient’s bedside.

In these series of videos, users with a basic knowledge of biomedical science and regulatory structures will explore in depth the policies and practices of regulatory research, review, and management for these product classes. They will be able to integrate this knowledge with scientific principles related to the development of experimental protocols and testing paradigms, in order to plan, critique and provide direction to complex device programs.

Big changes are underway in the U.S. medical device landscape. With the transition toward ISO 13485 harmonization now in motion, it’s important to understand what’s changing and what to prepare for. Dive into the latest MedTech Crossroads video, curated for the medical startup community and innovators focused on investing in and delivering better health across the globe.