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Regulatory Submission

Ultimate Guide to Device Class Requirements under EU MDR

May 22, 2024
Marketing a device in the European market means complying with the numerous safety and technical requirements of the Medical Device Regulation (MDR). In practice, this can be... Read More
Product Development

How are Medical Devices Classified under EU MDR?

May 1, 2024
One of the most important steps in bringing a medical device to market in the European Union (EU) is determining the correct classification for your device. Read More
Establishing a QMS

Definitive Guide to Change Management for Medical Devices

April 22, 2024
In an industry that is ever-evolving, change is inevitable. Read More
Regulatory Submission

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

April 8, 2024
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Regulatory Submission

Step-by-Step Guide to FDA PMA Submissions for Class III Medical Devices

April 2, 2024
The premarket approval (PMA) process is the method FDA uses to evaluate the safety and effectiveness of Class III medical devices before they can be placed on the US market. Read More
Product Development

How to Structure your Medical Device Technical File

March 5, 2024
The medical device technical file is a must-have document for devices to be sold in the EU marketplace. Read More
Establishing a QMS

ALM and Design Controls: Do SaMD and SiMD Manufacturers Need Both?

February 26, 2024
One consequence of the massive growth of software as a medical device (SaMD) and software in a medical device (SiMD) is the growing overlap between the realms of software... Read More
Establishing a QMS

How MHRA is Regulating Medical Devices in the UK after Brexit

February 22, 2024
If you would like to place a medical device on the United Kingdom (UK) marketplace, then changes in the regulatory landscape resulting from Brexit are relevant to you. Read More
Product Development

Selecting a Notified Body: How to Work with Your New Device Authority

February 1, 2024
Before you can market your product in the European Union, medical device manufacturers must undergo a conformity assessment carried out by a Notified Body (NB) in order to... Read More

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