SOCRA presents Device Research & Regulatory Webinar Series/Part I: Medical Device Research, Regulations and Path to the Marketplace

May 7, 2021
12:00 - 1:00 ET

12:00 – 1:00 pm ET    Medical Device Research, Regulations and Path to Marketplace

Kathi Durdon, MA, CCRP, Executive Director at CNY Biotech Accelerator, Upstate Medical University

Ms. Durdon will start this SOCRA virtual mini-series off with an overview of medical device regulations and how risk plays a prominent role in product development, regulatory submission and ultimately use by patients and caregivers.  This presentation will provide a brief history of medical device regulatory history, device classification, relevance of clinical trials and design for FDA submission, and the total product lifecycle of medical devices (TPLC).

Additional Series Dates:

Friday, May 14, 2021 - The Types of Device Trials, Billing and Reimbursement

Friday, May 21, 2021 - The Promise and Complications of "Broad Consent"

Registration Fees for entire Series:

Member Fee- $90

Non-Member Fee- $165*

*Non-Member Fees include a non-refundable one-year membership in SOCRA

Continuing Education Credit Hours:

SOCRA designates this educational activity for a maximum of 3 Continuing Education Credits for SOCRA CE and Nurse CNE. SOCRA designates this live activity for a maximum of 3 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Accreditation Statements:

CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

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