The Nemedio Blog:  Demystifying Compliance

your guide to product development and compliance for medical technology
Webinar - On Demand

The Compliance Journey, Part 2: Transitioning to Full Compliance

October 26, 2021

On November 10, 2021, Nemedio hosted the second installment of the Compliance Journey Webinar Series. You can view a recording of that webinar here on demand.

Overview

You've completed your company’s Pre-Compliance activities and are ready to take operations to the next level. Medical Devices, under the jurisdiction of the FDA, are required to comply with a set of rules and regulations to ensure safety and quality to protect patients and end users. During this talk, we will provide an overview of how to build on the Pre-Compliance activities you’ve completed to set up a Quality Management System to ensure full compliance in day-to-day business operations, as well as the design, manufacturing, and testing of your products. We will also review necessary Regulatory Affairs activities you’ll need to complete, as well as timing and guidance on when to ramp to a full compliance program within your company.

Learning Objectives

After this session, attendees should understand:

  • the Quality System regulations (21 CFR 820)
  • validation requirements for an electronic Quality System
  • components of a Quality System (i.e.: what is a SOPs and what do they cover)
  • the importance of a robust compliance training program and its impact on operations
  • specific regulations that apply to companies whose products contain software

RELATED

Chat with an Expert

Stuck on a particular problem? Speak with an expert to get your questions answered.