FREE ON DEMAND WEBINAR
May 25, 2023

Implementing Risk Throughout the Entire Product Lifecycle

Managing Risk throughout the product lifecycle, while remaining compliant with ISO 13485:2016 and ISO 14971:2019 requirements, is one of the biggest challenges the MedTech industry faces. 

According to the 2023 MedTech Industry Report, the biggest pains associated with Risk Management are:

• Lack of ownership across the product lifecycle
• Insufficient data and information to assess Risk
• Visibility & traceability with Risk documentation
• Keeping up with ISO 14971, and
  Continuously evaluating Risk as part of the post-market surveillance process

We’ve teamed up with HTEC Group to host a free, in-depth webinar where we’ll be sharing best practices and actionable tips for MedTech companies to effectively manage Risk across the entire medical device lifecycle. Participants will learn exactly what the regulations are asking for when it comes to Risk and which Risk activities you should be doing across different stages of the product lifecycle.

Specifically, this webinar will cover:

• Understand the current problems with risk management
• Learn how Risk is defined by ISO 14971:2019 & ISO 13485:2016
• Determine how you should be tackling Risk and Design Controls as an earlier-stage company
• Apply a risk-based approach to post-market surveillance
• Know what you should look for in a QMS as it relates to Risk Management
• Get a live look into Greenlight Guru’s brand-new Risk Management Software
• Q&A