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What are the Strategic Priorities for CDRH in 2021? - Featured Image

What are the Strategic Priorities for CDRH in 2021?

By Nick Tippmann on January 20, 2021
What are the 2021 strategic priorities for FDA’s Center for Devices and Radiological Health (CDRH) a...
Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape - Featured Image

Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

By Nick Tippmann on January 6, 2021
What impact has artificial intelligence (AI) and machine learning (ML) had on the medical device ind...
Why Biocompatibility Should be Addressed by Every Medical Device Company - Featured Image

Why Biocompatibility Should be Addressed by Every Medical Device Company

By Nick Tippmann on November 4, 2020
Should your medical device company address biocompatibility? The short answer is, yes. Every single ...
What is a Multiple Function Device? - Featured Image

What is a Multiple Function Device?

By Nick Tippmann on September 30, 2020
What is a multiple function device? From a high level, it’s a product with at least one portion that...
Challenges related to Home Use Devices - Featured Image

Challenges related to Home Use Devices

By Nick Tippmann on September 10, 2020
What could go wrong as more medical device products are used at home and in similar non-traditional ...
Submitting a 510(k) using FDA's Safety and Performance Based Pathway - Featured Image

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

By Nick Tippmann on September 2, 2020
What is FDA’s Safety and Performance Based Pathway and how does it relate to the Traditional, Specia...
How Jon Speer Met His Most Frequent Guest: Mike Drues - Featured Image

How Jon Speer Met His Most Frequent Guest: Mike Drues

By Nick Tippmann on August 26, 2020
Reminiscing about past and present lessons learned from listening to conversations with this show’s ...
How to Build a QMS for a Medical Device - Featured Image

How to Build a QMS for a Medical Device

By Nick Tippmann on July 8, 2020
Where do you begin when building a quality management system (QMS) for a medical device? It’s a task...
What is Regulatory Due Diligence for Medical Devices? - Featured Image

What is Regulatory Due Diligence for Medical Devices?

By Nick Tippmann on June 24, 2020
What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory s...
Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry - Featured Image

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

By Nick Tippmann on June 3, 2020
Most of us have read about, observed, participated in, and spoke with healthcare providers and medic...
How to Construct an Effective Regulatory Strategy - Featured Image

How to Construct an Effective Regulatory Strategy

By Nick Tippmann on May 27, 2020
What is a regulatory strategy? What are the components involved?
510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies - Featured Image

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

By Nick Tippmann on May 6, 2020
What does the 510(k) process involve? How should medical device companies know if this is the right ...

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