COVID-19 Industry Impact Benchmarks

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Modernizing your QMS to keep up with the Modern Age of Requirements

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eMDR Program and Process

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During this presentation we will explore where Medical Device Risk Management Systems are today. We will look at the quickly upcoming deadlines for implementing the ISO 14971:2019 3rd Edition, and EN ISO 14971:2019/A11:2021 standards. We will also mention the potential next (4th) edition of ISO 14971, and how the industry may influence the next edition. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.

Moving up to the State of the Art in Risk Management

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While ISO 13485 is written in black and white, the alignment between the standard's requirements and expectations is not always clear - especially in regards to SaMD (software as a medical device). This session will discuss aligning ISO 13485 with best practices for SaMD, and how we can expect the shift of the industry to impact the anchor standard of the medical device industry. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.

ISO 13485: What's Next?

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Computer Software Assurance (CSA): Understanding the FDA’s New Draft Guidance

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Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and ...

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We are operating in a complex environment, which is still undergoing changes. A lack of regulatory/quality management resources can be seen on both notified bodies and the industry. To overcome these hurdles, close collaboration and communication between companies and the notified body is necessary. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.

Reducing Friction Between Companies and Regulatory Bodies

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Latin American Regulations - What you Don't Know

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Insights on the MedTech Regulatory and Clinical Environment in Israel

Greenlight Guru

The regulatory landscape related to human factors and usability engineering has continued to evolve since FDA issued its draft guidance for human factors over ten years ago. In fact, the international standard for usability engineering, IEC 62366-1: 2015 was amended as recently as 2020. The good news is that the pathway to a successful regulatory strategy, in terms of human factors and usability engineering, has never been more clear. The regulators have spoken, by way of guidance and standards documents, all that is left to do is to make sense of it all as it relates to your specific device or product. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.

The Global Guide to Human Factors and Usability Engineering Regulations

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MDSAP Certification: Success and Failures

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QMSR Harmonization - The Good the Bad and the Ugly

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Unique Device Identification —aka UDI— is about more than barcodes and regulatory red tape. This global system for identifying medical devices is a chance to radically improve the quality of life for patients, providers, and producers of medical devices. However, implementing UDI into your product lifecycle means navigating differing requirements in both the United States and the European Union. If you’re looking to go global, we’ve brought together three industry leaders on the subject to make sure you know the difference. This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.

UDI - US vs EU: What You Need to Know

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State of Swexit/Brexit

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What is Regulatory Strategy? Why is Regulatory Strategy important? What is International Regulatory Strategy? Why is International Regulatory Strategy important? How early in the product development lifecycle should we consider international regulatory strategy? What’s the relationship between International Regulatory Strategy and International Reimbursement Strategy? This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.

Designing an International Regulatory Strategy: Why do so many get it wrong?

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UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates. This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines. This presentation originally aired during the 2021 State of Medical Device Virtual Summit.

Implementing a Global Unique Device Identification (UDI) Solution: Regional U...

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The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation. SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently. This presentation originally aired during the 2021 State of Medical Device Virtual Summit.

Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...

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With the COVID-19 crisis, the Medical Device Regulations (MDR) have been pushed back one year, this delay has given a respite for those companies that were not quite ready for the increase regulations. In this session, we will be discussing the current status of the medical device industry regarding MDR and what are others doing to get ready. This presentation originally aired during the 2021 State of Medical Device Virtual Summit.

A Delay in MDR: Where are We Now

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FDA caused quite a stir when it announced transformative changes to modernize its 510(k) program to improve the safety and effectiveness of medical devices. But as we all know, the more things change, the more they stay the same. If you dive deep into FDA’s statement, you’ll realize that there’s probably not a lot that’s different. In this session, Michael Drues, Ph.D., President of Vascular Sciences, will share what FDA's 510(k) Modernization means, any evidence that changes are happening, and what medical device manufactures need to know about 510k modernization. This presentation originally aired during the 2021 State of Medical Device Virtual Summit.

FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will C...

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Audits are a fact of life in the medtech industry, whether internal audits, supplier audits, or notified body audits. While previously most audits were conducted on-site and in person, the industry has had to pivot to remote auditing wherever possible. In this session, Cannon Quality Group founder/CEO Nicolle Cannon will share CQG’s experiences as an early adopter of remote auditing. CQG has conducted numerous internal and supplier audits remotely as well as supported clients undergoing remote notified body audits. The presentation will cover both the hard skills of getting comfortable with various technology platforms as well as the soft skills of effective communication between auditor and auditee. Many now predict remote auditing will remain the default option in the coming years. This presentation originally aired during the 2021 State of Medical Device Virtual Summit.

Audits: Let’s get back to Auditing, REMOTELY!

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Modernizing your QMS to keep up with the Modern Age of Requirements

eMDR Program and Process

Moving up to the State of the Art in Risk Management

ISO 13485: What's Next?

Computer Software Assurance (CSA): Understanding the FDA’s New Draft Guidance

Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and ...

Reducing Friction Between Companies and Regulatory Bodies

Latin American Regulations - What you Don't Know

Insights on the MedTech Regulatory and Clinical Environment in Israel

The Global Guide to Human Factors and Usability Engineering Regulations

MDSAP Certification: Success and Failures

QMSR Harmonization - The Good the Bad and the Ugly

UDI - US vs EU: What You Need to Know

State of Swexit/Brexit

Designing an International Regulatory Strategy: Why do so many get it wrong?

Implementing a Global Unique Device Identification (UDI) Solution: Regional U...

Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...

A Delay in MDR: Where are We Now

FDA's 510(k) Modernization: What if Anything has Changed? Is Changing? Will C...

Audits: Let’s get back to Auditing, REMOTELY!

COVID-19 Industry Impact Benchmarks

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