Clinical Login Support Contact Sales
Products

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

Learn More

Featured Capabilities:

Document Management Training Management CAPA Management Audit Management Product Development

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

View Product Tour

Accelerate development with integrated design control and risk software.

Learn More

Featured Capabilities:

Design Controls Risk Management Risk Intelligence

Schedule a custom demo of Greenlight Guru Product now.

REQUEST A DEMO

Data collection and management designed for MedTech clinical trials.

Learn More

Featured Capabilities:

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

Get a personalized demo of Greenlight Guru Clinical today.

Request a Demo
Solutions
Why Us
Customers
Partners
Company
Resources
ROI Report Cover

Calculate Your ROI
Pricing
Request a Demo
Request a Demo

Posts by Chris McHale

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

View Post
Establishing a QMS

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

Laura Maher
January 3, 2024
View Post
featured

Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
View Post

Filter All Blog Posts

About the Author

Chris McHale, Chief Executive Officer and Co-Founder, is responsible for the overall operational and financial success of SPK and Associates. Chris has over 25 years experience in the technology sector, starting in the trenches as a Unix consultant at Hewlett-Packard. She was the Business Manager of HP’s western professional services organization, before co-founding SPK in 1997. This early experience gave her a deep appreciation of the technology challenges faced by customers and engineers alike. She holds a BA with Honors from University of Virginia, and an MBA from UCLA’s Anderson School of Management.

Showing Results for

Product Development

Computer Systems Validation: How To Avoid FDA Warning Letters C.F.R. 820.70(i)

Chris McHale
January 27, 2023
Computer systems validation (CSV) is a standard regulatory exercise Med Device companies are required to complete. This is not new news. Read More

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