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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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Post-Market Surveillance

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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Product Development

Customer Discovery for Medical Device Companies

Etienne Nichols
November 2, 2022
What is the customer’s ecosystem, and why do you need to know about it? In today’s episode, we spoke with Kari Haab about Customer Discovery for Medical Device companies. Read More
Post-Market Surveillance

Why Investigator Initiated Studies Alone Are Not the Solution for PMCF Under EU MDR

Jon Bergsteinsson
October 27, 2022
The European Medical Device Regulation (EU MDR) requires medical device manufacturers to engage in post-market surveillance by establishing and implementing both a... Read More
Product Development

EUA and the Impending Transition

Etienne Nichols
October 26, 2022
There’s a transition underway for devices that are currently under an EUA. People may not realize it, but this EUA, which was put into place under COVID, covers more than... Read More
Post-Market Surveillance

Approved Supplier List: How To Add Suppliers to Your ASL in 7 Steps

Ben Bancroft
October 23, 2022
Your approved supplier list (ASL) is one of the critical components of medical device supplier management. The ASL is an in-house record of all the suppliers you’ve... Read More
Product Development

Common QMS Mistakes SaMD Companies Make

Etienne Nichols
October 20, 2022
What pitfalls do SaMD companies run into when they set up their QMS? How can your company avoid making these QMS mistakes? Read More
Establishing a QMS

Should ISO 15189 Certification Matter to Medical Device Companies?

Etienne Nichols
October 14, 2022
For medical device manufacturers, a medical laboratory can play a huge role in the success of a product. This is where many types of testing can occur. Whether it’s for... Read More
Product Development

Design Assurance: The Unsung Heroes of R&D

Etienne Nichols
October 13, 2022
What is design assurance, and what function does it serve in the overall product design process? It’s not a role that gets a lot of upfront credit or name recognition, but... Read More
Establishing a QMS

What You Need to Know About Risk Management and Using Post-Market Data

Jon Speer
October 11, 2022
The aim for any medical device company is always to ensure that the devices they make are safe and effective. Read More
Product Development

Lessons from an Industry Leader: Playing the Long Game of MedTech

Etienne Nichols
October 6, 2022
What does it mean to let your values and principles guide you through the challenging times, including the black swan events? Just what is a black swan event anyway? Will you... Read More

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