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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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Product Development

What "Exempt" Means with Respect to Medical Devices & Regulatory

Etienne Nichols
November 30, 2022
How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a device... Read More
Product Development

Developing a Regulatory Strategy

Etienne Nichols
November 23, 2022
What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn’t? Those are the questions that today’s guest, Mike Drues,... Read More
Product Development

Understanding Root Cause Analysis in the CAPA Process

Etienne Nichols
November 20, 2022
Corrective and preventive actions (CAPA) is a cornerstone to ensuring the quality of medical device manufacturing. Perhaps that’s the reason why improper CAPA procedures are... Read More
Product Development

We Achieved ISO Certification! Now what?

Etienne Nichols
November 16, 2022
What are ISO 9001 and ISO 27001? Once you have them, what can you do with them? These are the questions you’ll hear Mark Alpert answer in today’s episode. Read More
Product Development

The Future of Reprocessed Used Medical Equipment

Etienne Nichols
November 10, 2022
What’s accelerated the growth of online healthcare device sales, and what’s the future of regulation regarding selling used medical devices? In today’s episode, we spoke with... Read More
Product Development

The Difference Between Managing Product & Services Suppliers in MedTech

Ben Bancroft
November 6, 2022
Both the FDA’s Quality System Regulations and ISO 13485 require medical device manufacturers to implement purchasing controls. The goal of those controls is to ensure that... Read More
Product Development

The Importance of Cervical Cancer Screening in the U.S.

Etienne Nichols
November 4, 2022
The importance of cervical cancer screening in the U.S. Why is cervical screening so important in the U.S. and globally? And how has the pandemic affected that screening? Read More
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
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

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