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Product Development

3 Factors that Impact Application of Decentralized Clinical Investigations for Medical Devices

February 17, 2023
The COVID-19 pandemic drove a huge interest in the concept of decentralized clinical investigations. The pandemic forced many MedTech manufacturers to re-evaluate their... Read More
Establishing a QMS

Ultimate Guide to ISO 13485 for Medical Devices QMS

February 16, 2023
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MedTech Lifecycle Excellence

Part 2: The Theranos Loophole & Lab Developed Tests

February 15, 2023
In a continuation of the previous episode, Mike Drues joins the podcast to further discuss LDTs, IVDs, and how those related to the ongoing Theranos situation. Read More
Product Development

5 Processes You Need to Invest In to Bring a Device to Market

February 14, 2023
In our recent 2023 MedTech Industry Benchmark Report, one statistic really caught my eye: Companies are using an average of 9 software tools for medical device development. Read More
Product Development

How Electronic Data Capture is Transforming the MedTech Industry

February 14, 2023
Though MedTech is already among the fastest-evolving markets in the world, it doesn’t mean it couldn’t still benefit from a spark of innovation. Read More
Establishing a QMS

Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices

February 13, 2023
Table of Contents What is 21 CFR Part 820? Read More
Product Development

Beginner's Guide to Design Verification & Design Validation for Medical Devices

February 10, 2023
Design verification and design validation are two essential stages in design controls. It’s easy to confuse the two because they both involve checking an outcome against your... Read More
Product Development

What is a Document Control System?

February 10, 2023
Document control systems are the backbone of quality management systems in the medical device industry. Read More
MedTech Lifecycle Excellence

Part 1: The Theranos Loophole & Lab Developed Tests

February 9, 2023
What’s the difference between an LDT and an IVD and what does that have to do with the Theranos case? In this episode, we dig deep into this topic. Read More

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