IVDR Implementation: Key Considerations Amidst the Looming Deadline


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.

Get Tickets $10 – $15


You’ve got a great idea for a medical device! Now what? Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is absolutely crucial for clinical trial success. With the explosion...

Business of Healthcare


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

Get Tickets $10 – $25

University of Georgia: 8th Annual UGA/FDA Medical Device Regulations Conference

8th Annual Medical Device Regulations Conference September 21-23, 2021 Medical Device manufacturers and Innovators, Regulatory and Quality Assurance Professionals, Regulators and Academics are invited to attend the 8th Annual UGA/FDA Medical Device Regulations Conference! This conference is co-sponsored by the US Food and Drug Administration and the...