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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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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 Brittani Smith

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

Brittani Smith is a Medical Device Guru and Biomedical Engineer who has spent her career in the orthopedic industry working in regulatory, post-market surveillance on the quality team, and remediation engineering work. She also has experience in labeling software and transitioning from paper IFUs to electronic based. Brittani loves helping customers set up and improve their post-market surveillance and processes. Brittani enjoys digging into the weeds of all things regulations. She intimately understands how important it is to have a quality over compliance mindset in an organization. Brittani is equally as passionate ensuring improving quality of life is at the forefront of all she does and being able to help her customers do the same while establishing a QMS and bringing a product to market.

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Establishing a QMS

Ultimate Guide to Postmarket Surveillance of Medical Devices

Brittani Smith
February 26, 2023
The pursuit of MedTech Lifecycle Excellence requires that you consider the entire lifecycle of your medical device. This includes systematic monitoring of your device after... Read More

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