All "Medical Devices" articles

How Much Is the FDA Medical Device Registration Fee in 2022?

For the fiscal year of of 2022, the Food and Drug Administration (FDA) medical device registration fee rates increased by 2.5% from 2021. Considering ...

What all medical device founders should know with John Kapitan, CEO of Kapstone Medical

  Subscribe on any major podcast player. Today's guest, John Kapitan is the CEO of Kapstone Medical, a company he founded in 2007 after 15 years in ...

What is FDA Emergency Use Authorization

In recent months, the U.S. Food and Drug Administration (FDA) has used Emergency Use Authorizations (EUA) to accelerate the development and approval ...

What is a Device History Record (DHR)?

What is the best way to ensure that your medical device has been built with quality in mind? Many industry-leading medical device manufacturers rely ...

6 Essentials of a Clinical Evaluation Report (CER) for Medical Device Organizations

If you've never completed a medical device clinical evaluation report, you're probably concerned with how involved the report needs to be and how ...

What is the Device Master Record (DMR)?

The 21 CFR 820.181 regulation requires all medical device manufacturers to maintain concrete records related to device specifications, quality ...

3 FDA Design Control Requirements for Medical Device Startups

Did you know that design issues are the largest source of product recalls in the United States?  Poorly designed products pose a serious threat to ...

What Is the Unique Device Identification (UDI) System and Why Is it Important?

If you’re preparing to introduce a new medical device to market, labelers must first secure a unique device identifier.  In case you’re unfamiliar, ...

How Long Does the FDA Medical Device Approval Process Take?

How long before your medical device startup runs out of money? That depends on how long it takes before you start generating revenue. And generating ...

Regulatory Expectations for Software as a Medical Device (SaMD) Startups

To ensure that products are safe and effective for use, medical device manufacturers need to follow specific guidelines enforced by the U.S. Food and ...

What is the Global Unique Device Identification Database (GUDID)?

The U.S. Food and Drug Administration (FDA) created the Global Unique Device Identification Database (GUDID) as a labeling resource for medical ...

How to Get IEC 60601-1 Approval in 5 Easy Steps

For some medical device startups and scale-ups, achieving International Electrotechnical Commission (IEC) 60601-1 approval is easier said than done. ...
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