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Tag: biocompatibility

Reprocess of Single Use Devices: EU MDR Requirements

The requirements related to the reprocessing of single use devices are reported within Article 17 of EU MDR 2017/745. Several articles have been already...

SeaStar Medical Bolsters Operational Expertise with Appointment of Thomas R. Mullen as Vice President of Operations and Product Development

DENVER, COLORADO, Dec. 02, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq:ICU), (“SeaStar Medical” or the “Company”), a medical technology company developing proprietary...

ISO 17511: Metrological Traceability for IVD Medical Devices

A new version of ISO 17511 has been recently published and in this article we will dig into the requirements of this ISO standard,...

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...

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...

510k Electronic Submission Guidance for FDA 510k Submissions

Posted by Rob Packard on November 8, 2022 This article provides an overview of the new 510k electronic submission guidance document that...

Electrochemically Synthesized Poly(3-hexylthiophene) Nanowires as Photosensitive Neuronal Interfaces

Poly(3-hexylthiophene) (P3HT), a hole-conducting polymer, generates a lot of interest especially because of its excellent optoelectronic properties (such as good electrical conductivity and high...

Press Release: Shin-Etsu Chemical develops innovative new materials for wearable devices – Shin-Etsu MicroSi

Shin-Etsu Chemical Co., Ltd. (Head Office: Tokyo; President: Yasuhiko Saitoh) has developed innovative electrophysiological dry electrodes and high-elasticity wiring materials, which will be used...

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