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Medical Devices

Systems and Procedure Packs according to Article 22 of EU MDR

The requirements related to system and procedure packs are listed in the article 22 of EU MDR 2017/745. In this article, we are going...

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FDA Guidance on Post-Approval Studies: Study Protocols

The new article highlights the aspects related to study protocols for post-approval studies.  Table of Contents The Food and Drug Administration...

Intravascular lithotripsy shows tremendous growth

Intravascular lithotripsy (IVL) has shown to be an effective alternative to traditional atherectomy procedures such as excisional, laser ablation or rotational atherectomies (RAs); it...

Peijia Medical Limited and inQB8 Medical Technologies, LLC report Successful First-in-Human implantation of MonarQ Transcatheter Tricuspid Valve Replacement System

SUZHOU, China, Nov. 25, 2022 /PRNewswire/ -- inQB8 Medical Technologies, LLC (inQB8), in Partnership with Peijia Medical Limited (Peijia, (9996.HK)), announced today that it...

3D Bioprinting Guidelines Ask Your Input

NMPA issued a notice “Information Solicitation on New Materials and Product Performance Evaluation for Biological 3D Printing”. It says domestic and foreign enterprises, scientific...

ANVISA Guidance on SaMD: Various Supply Types

The new article provides additional clarifications regarding the regulatory status of software products with different types of supply, including software to be installed, cloud...

FDA Guidance on Deficiencies and the Least Burdensome Approach: Deficiency Letters

The new article describes in detail the aspects related to the content of deficiency letters, their review, as well as the way the authority...

MDCG Guidance on Authorized Representatives: Changes, Responsible Persons and Surveillance

The new article highlights the key points related to a change of authorized representative, as well as the ones related to responsible persons and...

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