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Establishing a QMS

What Impact Does a QMS & Regulatory Have on Fundraising and Pre-money Valuation?

June 16, 2022
How does a quality management system (QMS) and regulatory affairs impact fundraising, pre-money valuation, market access, and commercialization for medical device... Read More
Establishing a QMS

Greenlight Guru Unveils the World's First MedTech Lifecycle Excellence Platform to Enable Success Across The Entire Product Lifecycle

June 16, 2022
The new end-to-end platform for the MedTech Industry operationalizes process excellence across the entire product lifecycle Read More
Establishing a QMS

MedTech Lifecycle Excellence: Out of the Dark and into the Age of Enlightened Quality

June 16, 2022
During a less-than-heroic time in history, humans suffered through the Dark Ages with a lack of new technology and scientific advances. Read More
MedTech Lifecycle Excellence

Recap of True Quality 2022

June 12, 2022
True Quality 2022 featured one incredible MedTech speaker or panel after another.  Read More
Product Development

What Role Should Quality Play in Bringing a Medical Device to Market?

June 10, 2022
Bringing a medical device to market is a tall task for any company, and every department has to work cross-functionally to make it possible.  Read More
Product Development

Early Feasibility Studies in Latin America

June 8, 2022
Colombia represents an untapped destination for early feasibility, first-in-human clinical research for companies to first enter the Latin American market and sell medical... Read More
Product Development

Who are the Economic Operators & What Does EU MDR Require of Them?

June 5, 2022
There are four legal entities designated as economic operators under the European Union Medical Device Regulation (EU MDR):  Manufacturers Importers Distributors Read More
Product Development

Applying for International Patents as a Medical Device Company

June 3, 2022
Obtaining a patent (or patents) for your medical device is the best way to protect your intellectual property from being used by competitors. Read More
Establishing a QMS

Greenlight Guru Acquires Electronic Data Capture Solution SMART-TRIAL

June 2, 2022
The acquisition expands capabilities of Greenlight Guru’s industry-leading platform to simplify clinical data management for MedTech companies across the globe Read More

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