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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Posts by Nick Tippmann

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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About the Author

Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later acquired.

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Product Development

Shifting Sands of SaMD Cybersecurity Regulations

Nick Tippmann
July 5, 2022
FDA has issued new draft guidance on cybersecurity for software as a medical device (SaMD). If the FDA releases that draft guidance ‘as is,’ it will massively and negatively... Read More
Product Development

Early Stage Territory Planning for Medical Device Companies

Nick Tippmann
June 29, 2022
Do your field teams still rely on map, spreadsheet, and note apps? How medical device companies have historically generated sales is no longer adequate for selling medical... Read More
Establishing a QMS

Striving for Excellence: G2 Ranks Greenlight Guru #1 in Best Support, Best Usability, and Best Results for QMS

Nick Tippmann
June 23, 2022
Greenlight Guru is proud to announce that users have rated us as the leading QMS for the fifteenth consecutive quarter in G2’s Summer 2022 QMS Grid Report. Read More
Product Development

Regulatory & Quality Perspectives of 3D Printing in the Medical Device Industry

Nick Tippmann
June 22, 2022
What are the differences between 3D printing and additive manufacturing? What are the quality and regulatory considerations around 3D printing? What is FDA’s approach to... Read More
Establishing a QMS

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

Nick Tippmann
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 companies? Read More
Establishing a QMS

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

Nick Tippmann
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

Nick Tippmann
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
Product Development

Early Feasibility Studies in Latin America

Nick Tippmann
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
Establishing a QMS

Greenlight Guru Acquires Electronic Data Capture Solution SMART-TRIAL

Nick Tippmann
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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