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MedTech Lifecycle Excellence

AI, Automation, and Risk in MedTech

November 29, 2023
Most of us are quite comfortable using automations in both our personal and work lives. So much so that we barely think of them as automations anymore. Read More
MedTech Lifecycle Excellence

A Better Way to Develop A Medical Device with Digital and Physical Elements (Part 2 of 2)

November 28, 2023
InPart 1of this two-part blog post series, we explained why next-generation medical devices with hardware/software interactions need a new, holistic... Read More
MedTech Lifecycle Excellence

A Better Way to Develop a Medical Device with Digital and Physical Elements (Part 1 of 2)

November 28, 2023
InPart 1of this blog post series, we explain why next-generation medical devices with hardware/software interactions need a new, holistic development methodology. Read More
MedTech Lifecycle Excellence

Using AI in MedTech

November 22, 2023
In this episode, we delve into the burgeoning world of artificial intelligence in MedTech. Read More
Establishing a QMS

The Ugly Truth About Managing Design Controls on Spreadsheets

November 20, 2023
At one point in my career, after managing the design controls and risk management documentation, I decided to move on. Read More
MedTech Lifecycle Excellence

Becoming an Advisor to a Medical Device Company

November 16, 2023
In this episode, we delve into the multifaceted aspects of advisory roles within medical device startups. Read More
Establishing a QMS

Enterprise Quality Management Software: What You Need To Know

November 14, 2023
A quality management system (QMS) is simply a formalized system for documents, policies, procedures, and processes that companies in many industries—including MedTech—use to... Read More
Regulatory Submission

Recent FDA Draft Guidances

November 9, 2023
In this episode, we dissect the evolving landscape of FDA medical device regulations with regulatory expert Mike Drues. Read More
Product Development

Ultimate Guide to Supplier Management for Medical Device Companies

November 8, 2023
A medical device is only as good as its parts. Read More

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