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Greenlight Guru Medical Device Blog

Get the latest updates and best practices in the MedTech industry from our blog. Join 170,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Laura Maher
November 13, 2022

Ultimate Guide to IVDR for In Vitro Diagnostic Medical Device Companies

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Regulatory Submission

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

Jesseca Lyons
October 4, 2022
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Post-Market Surveillance

Selecting The Ideal PMCF Activity

Jon Bergsteinsson
July 17, 2022
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Product Development

Creating a Supplier Scorecard for Medical Device Supplier Management

Ben Bancroft
November 11, 2022
A supplier scorecard is one of the most effective tools medical device manufacturers have for assessing the performance of their suppliers. Read More
Product Development

The Future of Reprocessed Used Medical Equipment

Etienne Nichols
November 10, 2022
What’s accelerated the growth of online healthcare device sales, and what’s the future of regulation regarding selling used medical devices? In today’s episode, we... Read More
Regulatory Submission

Understanding FDA Cleared vs Approved vs Granted for Medical Devices

Tom Rish
November 10, 2022
As a medical device professional, you are well aware of how much time and effort goes into getting your product to market. So, with so much care put in every part of the... Read More
Product Development

The Difference Between Managing Product & Services Suppliers in MedTech

Ben Bancroft
November 6, 2022
Both the FDA’s Quality System Regulations and ISO 13485 require medical device manufacturers to implement purchasing controls. The goal of those controls is to ensure that... Read More
Product Development

The Importance of Cervical Cancer Screening in the U.S.

Etienne Nichols
November 4, 2022
The importance of cervical cancer screening in the U.S. Why is cervical screening so important in the U.S. and globally? And how has the pandemic affected that... Read More
Product Development

MDCG Guidance Documents Overview on Clinical Investigations and Evaluations

Jon Bergsteinsson
November 3, 2022
The EU Medical Device Coordination Group (MDCG) has provided a series of guidance documents for manufacturers to use on their path to MDR compliance. In April 2020, the... Read More
Product Development

Customer Discovery for Medical Device Companies

Etienne Nichols
November 2, 2022
What is the customer’s ecosystem, and why do you need to know about it? In today’s episode, we spoke with Kari Haab about Customer Discovery for Medical Device... Read More
Regulatory Submission

7 Tips to Comply With FDA 21 CFR Part 11

Jon Speer
October 28, 2022
When it comes to regulatory compliance for medical device companies, there can be some confusion around FDA 21 CFR Part 11.  Read More
Product Development

Why Investigator Initiated Studies Alone Are Not the Solution for PMCF Under EU MDR

Jon Bergsteinsson
October 27, 2022
The European Medical Device Regulation (EU MDR) requires medical device manufacturers to engage in post-market surveillance by establishing and implementing both a... Read More

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