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Software As A Medical Device – Definition and Classification in the EU, USA, China, and Japan

Oct 18, 2023 Software As A Medical Device – Definition and Classification in the EU, USA, China, and Japan

Webinar Overview

Navigating the intricate world of medical device regulations starts with understanding their classification and scope. Join our webinar as we delve into the pivotal realm of software in medical devices. Whether you’re in the EU, USA, China, or Japan, this presentation equips you with the knowledge you need to differentiate between software as a medical device and software used in medical devices.

This webinar will also present how C2P’s Product Compliance Solution can help achieve uninterrupted market access. 

C2P is an enterprise SaaS platform providing everything you need to take control of regulatory compliance and ensure market access in over 195 countries worldwide. Identify relevant regulations worldwide, communicate requirements, & provide evidence that your product is ready to go to market. C2P helps you relieve your team of manual fact-finding tasks and enable them to focus on critical business initiatives.

Webinar Agenda

This webinar will cover the following key topics:

  • Definition and classification rules of software as a medical device (SaMD)  and software used in medical devices
  • Comparative Analysis of the Regulatory Approaches of SaMD and software used in medical devices
  • Practical Guidance and Examples to illustrate the differences in  SaMD and software used in medical devices 
  • C2P – Product Compliance Solution

Date

This webinar took place on Wednesday, 8th November at 08:00 PDT, 11:00 EDT, 17:00 CET. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

Presenters

Amy Chen

Amy Chen,  MA Regulatory Consultant, Compliance & Risks

A market access & regulatory consultant with Compliance & Risks, Amy specializes in consumer products compliance, focusing on China, Japan, South Korea and other Asian countries.

She helps product manufacturers to identify and understand the regulations in place in the markets to which they sell by helping them to map their obligations with regard to product safety (chemicals, EMC, radio frequency), labeling, energy efficiency, waste and packaging.

Vish Karasani, Product Marketing Manager, Compliance & Risks

Vish Karasani, Product Marketing Manager, Compliance & Risks

Vish has over 8 years of international experience working in highly competitive industries and at hyper-growth startups.

An avid storyteller – her product marketing philosophy begins with listening to Compliance & Risks’ customers, understanding their pain points, solving for their problems and building for their future.

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