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

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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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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
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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Regulatory Submission

Exploring Breakthrough Device Designation

Etienne Nichols
August 25, 2023
In this episode of the Global Medical Device Podcast, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. Read More
Product Development

What is the FDA Medical Device Registration Process?

Laura Court
August 22, 2023
To patients and providers, medical devices are more than a product. They serve as the conduit to better quality of life for patients, improve diagnostic speed and accuracy,... Read More
Post-Market Surveillance

How to Comply with HIPAA and EU GDPR in Medical Device Studies

Chris Rush
August 17, 2023
The U.N. recognizes privacy as a fundamental human right, and nowhere is this more important than in medical data. That’s why both the US and the EU have regulations in place... Read More
Establishing a QMS

Conducting Quality Investigations in Medical Device Manufacturing

Etienne Nichols
August 11, 2023
When a quality event, like a product or process nonconformance, occurs in the manufacturing of medical devices, there’s a chance that the safety and efficacy of any affected... Read More
Establishing a QMS

Omnibus Act Impact on Medical Device Cybersecurity

Naomi Schwartz
August 7, 2023
The ‘‘Consolidated Appropriations Act, 2023’’ (H.R. 2617) was passed by the U.S. Senate and signed into law by President Biden on December 29, 2022. Read More
Product Development

How to Improve Detecting, Correcting, and Preventing Nonconformances

Etienne Nichols
July 17, 2023
If you work at a MedTech company, nonconformances are a fact of life. As long as there is still a human element in the development and manufacture of medical devices, there... Read More
Establishing a QMS

Ultimate List of ISO Standards for Medical Devices

Tom Rish
July 14, 2023
The International Standardization Organization (ISO) is an independent, non-governmental organization that has created thousands of international standards for numerous... Read More
Establishing a QMS

eQMS Buyer’s Guide: Making the Business Case for a New QMS Solution

Etienne Nichols
July 6, 2023
You know you need a new QMS solution. You may even have your sights set on an eQMS that you’ve evaluated and believe is the best option for your organization. Read More
Product Development

Identifying and Evaluating Medical Device Importers

Etienne Nichols
July 3, 2023
Expanding into new foreign markets is an exciting chapter for any medical device manufacturer. Read More

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