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Establishing a QMS

The Ugly Truth About Managing Design Controls on Spreadsheets

November 20, 2023
At one point in my career, after managing the design controls and risk management documentation, I decided to move on. Read More
MedTech Lifecycle Excellence

Becoming an Advisor to a Medical Device Company

November 16, 2023
In this episode, we delve into the multifaceted aspects of advisory roles within medical device startups. Read More
Establishing a QMS

Enterprise Quality Management Software: What You Need To Know

November 14, 2023
A quality management system (QMS) is simply a formalized system for documents, policies, procedures, and processes that companies in many industries—including MedTech—use to... Read More
Regulatory Submission

Recent FDA Draft Guidances

November 9, 2023
In this episode, we dissect the evolving landscape of FDA medical device regulations with regulatory expert Mike Drues. Read More
MedTech Lifecycle Excellence

The AI in MedTech Trend Report 2023 Is Here

November 7, 2023
At Greenlight Guru, when we want to know exactly what’s happening in the MedTech industry, we like to go to the source: the medical device professionals who work every day to... Read More
MedTech Lifecycle Excellence

Greenlight Guru Releases The AI in MedTech Trend Report 2023

November 7, 2023
The survey of more than 200 medical device professionals is a snapshot into the interest and attitudes toward AI tools and their adoption in the MedTech industry. Read More
Establishing a QMS

CAPA Process: Step-by-Step Instructions [+ Free Infographic]

November 3, 2023
The CAPA process is a frequent topic of discussion here at Greenlight Guru, mainly because it’s still such a big issue for medical device companies. Year after year, CAPA... Read More
Regulatory Submission

Planning an FDA Submission

November 2, 2023
In this episode, Etienne Nichols and Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dive deep into the... Read More
Establishing a QMS

Benefits of Switching from MasterControl to Greenlight Guru

November 2, 2023
At Greenlight Guru, we pride ourselves on building products specifically for MedTech companies. With more than 1,100 customers worldwide, we take our mission to move MedTech... Read More

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