Events

Do you have a novel biotech idea but need help bringing it to market? What regulations may impact your product development? How much money will you need and where to raise it? Which ideas investors fund and why? And finally, how do you convince healthcare providers and patients to use your invention? OCRA has partnered with the Small Business Development Center (SBDC)@UCI Beall Applied Innovation to present a Business of Healthcare event. Local entrepreneurs, investors, marketing strategy experts will share their valuable knowledge and real-life experiences in what it takes to turn an idea into a successful venture. Understand the correlation between risk management, clinical evaluation, and other post market surveillance activities to ensure the necessary linkages and references needed in multiple QMS procedures in order to comply with new Global Regulatory expectations

As the IVDR implementation looms closer this program will provide valuable feedback and lessons learned from two thought leaders that are working closely on multi-product IVDR certifications. The program will address most recent developments of IVDR, including a status update about notified bodies and implementation deadlines. We will address possible points of confusion between MDR and IVDR as well as share best practices and pitfalls to avoid.

Emerging Technologies and Combination products can advance patient therapy by combining and utilizing innovative technologies to deliver treatment. Although these products can be beneficial and lifesaving to the patient, industry may find it difficult to develop and maintain a sound, consistent approach to lifecycle management. Industry is keenly aware that the key to ensuring quality and safety in the lifecycle of a combination product is effective risk management.

U.S. Food and Drug Administration granted Dexcom a De Novo request for the Dexcom G6® CGM System, the newest generation of CGM for people with diabetes ages 2 and up. The purpose of this presentation is to share best practices around expanding an indication to include pediatrics. Coupled with providing a simple and effective ecosystem for parents & caregivers meant improved diabetes management for children and reduced finger sticks. The Dexcom G6 is indicated by the FDA for use as both a standalone CGM and for integration into automated insulin dosing (AID) systems.