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Greenlight Guru

@greenlightguru

Modern purpose-built, cloud-based solutions for medical device companies to bring products to market faster, more efficiently, and with less risk.

 Indianapolis, IN
Greenlight.Guru
Joined March 2014
  • Tweets8.8K
  • Following6.5K
  • Followers10.5K
1.8KMedia
Photo by Greenlight Guru (@greenlightguru)Photo by Greenlight Guru (@greenlightguru)Photo by Greenlight Guru (@greenlightguru)Photo by Greenlight Guru (@greenlightguru)Photo by Greenlight Guru (@greenlightguru)Photo by Greenlight Guru (@greenlightguru)Photo by Greenlight Guru (@greenlightguru)Photo by Greenlight Guru (@greenlightguru)Photo by Greenlight Guru (@greenlightguru)Photo by Greenlight Guru (@greenlightguru)
The “just enough” QMS: what does your pre-market team really need? - Learn how to build a 'just enough' Quality Management System (QMS) for early-stage medtech companies to ensure compliance without unnecessary complexity. hubs.ly/Q03YF70p0
A right-sized QMS: what does your pre-market team really need?

A right-sized QMS: what does your pre-market team really need?

Learn how to build a right-sized Quality Management System (QMS) for early-stage medtech companies to ensure compliance without unnecessary complexity.

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Did Christmas come early to the EU? Proposal to simplify EUMDR - The EU Commission has proposed a change to EU MDR to simplify and streamline the regulation. Here's what you need to know. hubs.ly/Q03YDwK00
Did Christmas come early to the EU? Proposal to simplify EUMDR

Did Christmas come early to the EU? Proposal to simplify EUMDR

The EU Commission has proposed a change to EU MDR to simplify and streamline the regulation. Here's what you need to know.

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Most popular medical device content in 2025 hubs.ly/Q03YtrdJ0
Most popular medical device content in 2025

Most popular medical device content in 2025

Most popular medical device quality, regulatory and product development content of 2025 from Greenlight Guru, including blog, webinar, and podcast content.

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What FDA investigators will look for under QMSR bit.ly/3KPLuLI
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Do ISO 13485's Production Controls apply to SaMD? bit.ly/4rKrGKc
Do ISO 13485's Production Controls apply to SaMD?

Do ISO 13485's Production Controls apply to SaMD?

This episode explores applying ISO 13485 to SaMD, covering virtual production, SOUP, SBoM, CSA, and managing agile updates with rigor.

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Maximize your runway: a strategic approach to compliance before your first QA hire bit.ly/3MiHVxV
Maximize your runway: a strategic approach to compliance before your first QA hire

Maximize your runway: a strategic approach to compliance before your first QA hire

Here's how to stay compliant while avoiding over-expansion of your team in the early days of a medtech company.

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Future of Medtech Virtual Summit Recap: Here’s What You Missed hubs.ly/Q03VRTt50
Future of Medtech Virtual Summit Recap: Here’s What You Missed

Future of Medtech Virtual Summit Recap: Here’s What You Missed

If you missed the Future of Medtech Virtual Summit, then here's your chance to get a full recap of the day and choose which sessions to watch on-demand.

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hubs.ly/Q03TMS8N0
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The future of quality systems in medtech bit.ly/4qee2OH
Fast, flexible, compliant: the new standard for medtech QMS

Fast, flexible, compliant: the new standard for medtech QMS

Medtech is going through a generational change right now, and nowhere is that more clear than in quality management. Here's what to expect.

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How a Government Shutdown Affects FDA Medical Device Regulation bit.ly/4nTveao
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Inside the Investor's Mind: What VCs Look For in MedTech bit.ly/3KlFOsq
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SaMD Clinical Evaluation: What Do the FDA and IMDRF Say? bit.ly/3VvdfuL
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MedTech Startup Survival Guide with Steve Bell bit.ly/48dy5qj
MedTech Startup Survival Guide with Steve Bell

MedTech Startup Survival Guide with Steve Bell

Avoid common pitfalls in MedTech with entrepreneur Steve Bell. Learn why most startups fail, how to validate your idea, and the key steps to building a successful medical device business.

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Top 50 Venture Capital Firms for Medical Device Startups bit.ly/48lTAF5
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What do VCs look for in medtech and life sciences startups? (webinar recap) bit.ly/4oTLkSI
What do VCs look for in medtech and life sciences startups? (webinar recap)

What do VCs look for in medtech and life sciences startups? (webinar recap)

Want to know what investors are thinking when they evaluate your company? Here's what's going on inside a medtech investor's mind.

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Dynamic risk management for software-enabled medical devices bit.ly/4m9fu2A
Dynamic risk management for software-enabled medical devices

Dynamic risk management for software-enabled medical devices

For software-enabled devices, spreadsheets can't keep up with risk management. Here's how Dynamic Risk Management can help.

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We sat down with Solas BioVentures to uncover how their hands-on approach is fueling early-stage innovation in a tough VC climate—rooted in IP strength, founder support, and strategic execution. You can see the full video here: bit.ly/4msikPV
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Bringing a software-enabled medical device to market is hard. Figuring out FDA, EU MDR, and ISO 62304 shouldn't be. Grab our no-fluff guide to SaMD: ✔️ Classification (US vs EU) ✔️ Docs that matter ✔️ AI/ML + postmarket tips 👉 bit.ly/3JiW4tn #SaMD #MedTech
Image from Greenlight Guru (@greenlightguru)
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Happening tomorrow! Don’t miss a live taping of The Global Medical Device Podcast with Etienne Nichols of Greenlight Guru and Joshua Eckelberry from Solas BioVentures. 🎧 Tune in for real talk on funding success in MedTech. 📅 Save your spot: bit.ly/46EP6Jb
Image from Greenlight Guru (@greenlightguru)
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Carrying out a supplier audit: when and how to audit your suppliers bit.ly/44DV4XM
Carrying out a supplier audit: when and how to audit your suppliers

Carrying out a supplier audit: when and how to audit your suppliers

Supplier audits are a critical part of a good supplier management program. Here’s when and how to audit your suppliers.

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