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

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Document Management Training Management CAPA Management Audit Management Product Development

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Accelerate development with integrated design control and risk software.

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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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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

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Posts by Jamie Bihary

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
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Chris Rush
April 12, 2024

Ultimate Guide to Clinical Data Management in MedTech

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Establishing a QMS

FDA Publishes Final Rule on QMSR

Etienne Nichols
February 2, 2024
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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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About the Author

Jamie Bihary is a Medical Device Guru at Greenlight Guru who has spent her career working in various roles ranging from R&D to Quality Engineering. As a Biomedical Engineer specializing in Tissue Engineering, she started her career in collagen-based Medical Devices and is interested in Advanced Wound Care Management. Jamie enjoys using her internal ISO 13485 Auditing skills to assist customers with the Onboarding Process at Greenlight Guru when it comes to establishing their eQMS.

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MedTech Lifecycle Excellence

How to Use the Turtle Diagram for Better Internal Audits

Jamie Bihary
February 9, 2024
An internal audit can be an overwhelming prospect, especially if you’re new to the company or internal auditing in general. Read More

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