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Preparing for Remote and On-Site Inspections and Audits - Featured Image

Preparing for Remote and On-Site Inspections and Audits

How can medical device companies be better prepared for remote and on-site inspections and audits? P...
How does EU MDR impact your Quality Management System? - Featured Image

How does EU MDR impact your Quality Management System?

The new medical device regulation in the European Union (EU MDR) has introduced a host of new challe...
Virtual Auditing in a Post-COVID World of Digital Compliance - Featured Image

Virtual Auditing in a Post-COVID World of Digital Compliance

What do auditing and compliance protocols look like during a pandemic? Medical device companies cont...
5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes - Featured Image

5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes

Your internal quality audits should be much more than a “checkbox” requirement on your compliance to...
Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View - Featured Image

Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View

Keeping a constant pulse on current medical device industry standards for risk management, like ISO ...
Prioritizing Medical Device Reimbursement During Product Development - Featured Image

Prioritizing Medical Device Reimbursement During Product Development

Medical device reimbursement is a key consideration that must be well researched, understood, and ma...
Definitive Guide to Change Management for Medical Devices - Featured Image

Definitive Guide to Change Management for Medical Devices

In an industry that is ever-evolving, change is inevitable.
What are the Strategic Priorities for CDRH in 2021? - Featured Image

What are the Strategic Priorities for CDRH in 2021?

What are the 2021 strategic priorities for FDA’s Center for Devices and Radiological Health (CDRH) a...
How to Use the De Novo Pathway for your Medical Device - Featured Image

How to Use the De Novo Pathway for your Medical Device

Is the De Novo regulatory pathway a viable option to get your medical device to market?
Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape - Featured Image

Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

What impact has artificial intelligence (AI) and machine learning (ML) had on the medical device ind...
Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry - Featured Image

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

Are you prepared for the aftermath of the pandemic’s impact on the medical device industry? It may b...
Most Popular Medical Device Content in 2020 from Greenlight Guru - Featured Image

Most Popular Medical Device Content in 2020 from Greenlight Guru

Thank you for helping make 2020 another exciting and record-breaking year for Greenlight Guru!

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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