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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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Featured Capabilities:

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 Sara Adams

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

Sara Adams is a Medical Device Guru at Greenlight Guru and a Certified ISO 13485 Lead Auditor who began her career in the medical device industry in the post-manufacturing world. As an experienced Quality Engineer, she has been responsible for leading Corrective and Preventive Action (CAPA) investigations and implementations, process improvements, and supplier and regulatory audits. Sara believes Quality is the responsibility of all medical device professionals, regardless of role or function, and enjoys helping customers achieve a state of constant audit-readiness by establishing and leveraging their medical device QMS software to improve the quality of life for patients.

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Establishing a QMS

5 Postmarket Surveillance System Musts for Every EU Manufacturer

Sara Adams
August 22, 2021
Designing, developing, and getting your medical device approved and onto the market is a huge accomplishment—but it isn’t the end of your responsibilities. Read More
Establishing a QMS

Choosing and Managing Your Medical Device Suppliers

Sara Adams
July 9, 2021
Managing your medical device suppliers is a core responsibility of manufacturers. Read More
Establishing a QMS

5 Tips to Improve your Medical Equipment Quality Assurance Activities

Sara Adams
May 14, 2021
You’ve just finished designing what appears to be the perfect medical device. It accomplishes its primary objective of helping care providers, it’s affordable, it’s lighter... Read More
Product Development

How to Create a Quality Management Plan

Sara Adams
February 9, 2021
Technically speaking, you can launch a product without a quality management plan—but most of your go-to-market efforts will feel as though you’re shooting from the hip and... Read More
Product Development

Change Management Process Explained in 6 Easy Steps (+ free template)

Sara Adams
January 19, 2021
In Prosci’s research, participants were six times more likely to meet project goals by following an excellent change management process. Read More

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