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Medical Device Quality Articles & Analysis

18 news found

THY Precision - Plastic Injection Moulding for Medical Devices: A Basic Overview

THY Precision - Plastic Injection Moulding for Medical Devices: A Basic Overview

Many medical devices are manufactured through plastic injection moulding, which allows for precise and top-quality components in large-scale production and better aligns with ISO standards. ...

ByHong Yang Precision Industry Co., Ltd.


STEMart Announces Balloon Catheter Testing Services to Ensure Medical Device Safety and Regulatory Compliance

STEMart Announces Balloon Catheter Testing Services to Ensure Medical Device Safety and Regulatory Compliance

STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter Testing Services for the development of safe and effective medical devices. ...

BySTEMart


Ushered In The "Medical Device" Performance Growth Rate "Spring"

Ushered In The "Medical Device" Performance Growth Rate "Spring"

In recent years, with the improvement of people's living standards and the pursuit of a healthy life, the medical device industry has developed rapidly. The demand for high-precision metal parts for medical devices has also increased. In terms of market size, the size of China's medical device ...

ByShenzhen Yujiaxin Tech Co., Ltd


Testing Your Bone Density for Osteoporosis Awareness Month

Testing Your Bone Density for Osteoporosis Awareness Month

Once osteoporosis is diagnosed, there is no way for it to be reversed, so making bone density testing a regular part of your medical routine can at least help manage its effects on the body. Our medical devices use the highest level of technology to successfully test bone density and test the body with quality ultrasound and ...

ByBeamMed Inc.


Acumed Acquires Exsomed to Enhance Its Portfolio of Upper Extremity Solutions

Acumed Acquires Exsomed to Enhance Its Portfolio of Upper Extremity Solutions

” About Acumed, LLC Acumed serves highly skilled, specialized surgeons who demand comprehensive, high-quality medical devices for patients with simple to complex injuries for optimal restoration of function. ...

ByExsoMed Corporation


NuShores welcomes a new Quality and Regulatory medical device professional to Little Rock

NuShores welcomes a new Quality and Regulatory medical device professional to Little Rock

Sam will show us how to make quality a lifestyle at NuShores. And he will work with our experts to finalize and submit our first medical device for consideration by the FDA for use in humans. ...

ByNuShores Biosciences LLC


Bluejay Diagnostics Appoints Edwin Rule as Vice President, Regulatory, Quality and Compliance

Bluejay Diagnostics Appoints Edwin Rule as Vice President, Regulatory, Quality and Compliance

In addition, he brings vast experience in FDA medical device submissions, Quality/Regulatory requirements for documentation, records and process qualification and Quality System Auditing. ...

ByBluejay Diagnostics, Inc.


Hyalex Receives ISO 13485 Certification

Hyalex Receives ISO 13485 Certification

We are happy to announce that Hyalex Orthopaedics has received ISO 13485:2016 certification for Medical Device and Quality Management Systems. This certification is a regulatory requirement and international standard outlining requirements for a medical device quality management system. ...

ByHyalex Orthopaedics, Inc.


Guided Therapeutics Receives News from Chinese State Food and Drug Administration that LuViva Meets Product Technical Requirements

Guided Therapeutics Receives News from Chinese State Food and Drug Administration that LuViva Meets Product Technical Requirements

(OTCQB: GTHP), the maker of the LuViva™ Advanced Cervical Scan, based on its patented biophotonic technology, announced today its Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corporation (SMI), has received notice from the Jinan Medical Device Quality Supervision and Testing ...

ByGuided Therapeutics, Inc.


Exsomed Corporation Announces Completion of MDSAP Certification and ISO 13485:2016 Audit With Zero Findings

Exsomed Corporation Announces Completion of MDSAP Certification and ISO 13485:2016 Audit With Zero Findings

ExsoMed Corporation, a privately held U.S.-based medical device company providing orthopaedic surgeons with innovative solutions in hand surgery, announced that it has successfully completed Medical Device Single Audit Program (MDSAP) certification and ISO 13485:2016 audits, with no open findings. MDSAP is a program that allows ...

ByExsoMed Corporation


Learn About Computrol’s Rapid Prototyping Capability at APEX

Computrol maintains its ISO 9001-2008 certification, ISO 13485 specific to medical device quality systems, AS9100 specific to military and aerospace quality systems, IPC class II and III and J-Std certified as well as being ITAR registered and lead-free RoHS ...

ByCreation Technologies


Optim LLC awarded Defense Logistics Agency (DLA) Capital (ECAT) Contract

Optim LLC awarded Defense Logistics Agency (DLA) Capital (ECAT) Contract

“The ECAT contract award allows for us to provide the Department of Defense with our most advanced medical products”, stated Doug Hughes, President and CEO of Optim. ...

ByOptim LLC


Pollet Medical Group integrates Hemotech & Hema.T Medical

Pollet Medical Group integrates Hemotech & Hema.T Medical

Pollet Medical Group, part of Pollet Group and mainly known for its water treatment activities under Pollet Water Group, integrates Hemotech & Hema.T Medical into their group. Both French companies are renomated experts in the market of hemodialysis and apheresis for dialysis centres and hospitals. Hemotech & Hema T. Medical deliver ...

ByPollet Water Group NV


SteriLux has received ISO 13485:2016 certification

SteriLux has received ISO 13485:2016 certification

We are excited to announce that SteriLux has received ISO 13485:2016 certification for Medical Device and Quality Management Systems from Lloyd’s Register. This ISO certification indicates that the company’s quality management system meets the most current regulatory requirements specific to the ...

BySteriLux SA


RegScan™ Releases Quality Suite Checklists™

RegScan™ Releases Quality Suite Checklists™

-based compliance management company, is pleased to announce the development of its latest innovation, Quality Suite Checklists™. For more information go to http://tinyurl.com/ksbwcm2 Quality Suite Checklists™ are designed to help you implement Quality Management Systems and quality processes. ...

ByRegScan - by Enhesa


Renishaw opens dedicated healthcare facility at its South Wales site

Renishaw opens dedicated healthcare facility at its South Wales site

The Centre, which was formally opened on 29th September by The Rt Hon Carwyn Jones AM, First Minister of Wales, provides a facility for the manufacture of custom medical devices, as well as education and training for the life sciences community. ...

ByRenishaw plc


ASTM F2038 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials

ASTM F2038 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials

4.1 This guide is intended to provide guidance for the specification and selection of silicone materials for medical device applications. Silicone manufacturers supplying materials to the medical device industry should readily provide information regarding non-proprietary ...

ByASTM International


ASTM F2042 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication

ASTM F2042 - 00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication

This guide is intended to provide guidance for the specification and selection of fabrication methods for silicones used in medical devices. It also provides guidance relative to testing that might be done to qualify lots of acceptable material, based on desired performance properties. Silicone ...

ByASTM International

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