Regulatory Submission

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

February 26, 2023

Ultimate Guide to Postmarket Surveillance of Medical Devices

View Post

Regulatory Submission

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

October 4, 2022

View Post

Post-Market Surveillance

Selecting The Ideal PMCF Activity

Jon Bergsteinsson

July 17, 2022

View Post

Filter All Blog Posts

Product Development

4 Advantages of an eQMS Over a Paper-Based QMS

Etienne Nichols

One of the biggest factors that determine a medical device company’s success is how effectively they manage quality processes. Read More

Product Development

How to Handle Medical Device Adverse Events

Etienne Nichols

Medical device adverse events can be a daunting challenge for any manufacturer to address. Read More

Product Development

Electronic Data Capture Systems vs. Paper-based Data Collection

Jon Bergsteinsson

In this blog, we’ll be comparing electronic data capture (EDC) systems to paper-based data collection systems. To do so, we’ll be reviewing four independent studies: ... Read More

Product Development

Making the BOM & Design Controls Connection

Your bill of materials (BOM) is a comprehensive list of all the materials and parts required to build your device, as well as directions for how to use them and where to... Read More

Product Development

Clinical Data Management System (CDMS) for Medical Device Clinical Trials

Páll Jóhannesson

For MedTech firms running clinical investigations on medical devices, clinical data management is the process of collecting and managing research data to produce high-quality... Read More

Product Development

Top 30 MDCG Guidance Documents for Medical Device Companies

Etienne Nichols

The Medical Device Coordination Group (MDCG) is a regulatory body made up of industry experts appointed by each of the member states of the European Union. Read More

Product Development

Top 40 IMDRF Technical Documents for Medical Devices

Etienne Nichols

The International Medical Device Regulators Forum (IMDRF) is a global organization on a mission—a mission to enhance the safety and quality of medical devices and promote... Read More

Product Development

Complying with Good Clinical Practice in Clinical Data Collection

Jon Bergsteinsson

For medical device manufacturers, clinical data is more than a collection of numbers and statistics—it’s a snapshot of the lives of patients you’re trying to help. And while... Read More

Establishing a QMS

21 CFR Part 11: A Complete Guide

Etienne Nichols

Medical device companies that wish to sell their devices in the US and EU must implement a quality management system that meets the requirements of 21 CFR Part 820 and ISO... Read More

1
2
3
4
5
Next

Experience the Guru Edge

Our industry expertise extends beyond our software. Explore our other resources that are helping leading MedTech companies reach success.

Academy

Accelerate your learning and proficiency - both in Greenlight Guru solutions and industry best practices. You’ll be equipped to build key competencies for your teams.

Elevate Your Education

Community

You're not alone. We created a network of peers to connect with and learn from. At any stage of the product development lifecycle, become part of our community to accelerate your path to excellence.

Find Your Community

Partner Ecosystem

We have over 200 strategic partnerships with leading consultants in quality, regulatory, testing, design, and clinical.

Become a Partner

Resources

Do you have a unique problem that needs solving? Or maybe you’re just looking to elevate your expertise. If you're a MedTech professional looking to improve the quality of life for your patients, we have the right resources for you.

Explore Our Content Hub