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

Watch the webinar

Implementing Risk Throughout the Entire Product Lifecycle
Who should attend? 
  • Risk Professionals and Management
  • Quality Professionals and Management
  • Medical Device Executives
  • Product Development Engineers and Management
  • R&D Engineers and Management
Register Now  

Hosted by

Miloš Cigoj
Miloš Cigoj

Quality and Compliance Lead,
HTEC Group

Hristina Panovska HTEC
Hristina Panovska

Engineering & Delivery Lead,
HTEC Group

Etienne Nichols

Medical Device Guru,
Greenlight Guru

Greenlight Guru logo

About Greenlight Guru

Greenlight Guru is the leading cloud-based platform purpose-built for MedTech companies. The end-to-end solution goes beyond traditional QMS needs by integrating cross-functional teams, processes, and data throughout the entire product lifecycle so device makers can proactively overcome execution gaps, streamline compliance, and accelerate market success.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk.

Visit our homepage to learn more.


About HTEC Group

HTEC Group is a global, digital, product development and engineering services firm powering the technological evolution of the world's most impactful organizations – from disruptive startups to Fortune 500 companies. With more than 2,000 experts spread across Central and Southeast Europe and consulting, innovation, and product design offices in Silicon Valley, New York, and London and extensive experience across business domains – including Healthcare, Retail, Transportation and Smart Mobility, Logistics, FinTech, Green Energy, Media, and Deep Technology – HTEC is both an ideal technology partner for its clients and the ultimate growth platform for its employees.

Visit their website to learn more.

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