Newsletter | September 12, 2023

09.12.23 -- Korean GMP: MFDS Requirements For Audits

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FEATURED EDITORIAL

Korean GMP: MFDS Requirements For On-Site And Document Audits Of Medical Device Manufacturing Plants

By KangKeun (Daniel) Lee, Freyr Solutions

If your medical device or in vitro diagnostics company is looking to enter the South Korea market, you will need to comply with the Korea Good Manufacturing Practice (KGMP) standards and requirements. This article shares a thorough overview of the requirements, including new information about audits that went into effect at the beginning of 2023.

INDUSTRY INSIGHTS

DC Brushless Servo Motors: Powerful Precision In A Petite Package

Article | By Koji Mizobata, Canon USA, Inc. Optoelectronic Components

Canon DC brushless servo motors’ combination of compact size, high torque, precision positioning, and high response make them ideal for medical and industrial applications.

The Benefits Of Aqueous Critical Cleaning In Pharmaceutical Manufacturing

Article | By Malcolm McLaughlin and Jeff Phillips, Alconox Inc.

The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of efficacy, minimal surface contact, reduced residue potential, and easier cleaning validation.

Unlocking Liquid Crystal Polymer Benefits For Wearable Injectors

Application Note | By Rob Haley, Dave Pellegrino, and Wim Vos, Celanese

Choosing the superior LCP polymer over traditional thermoplastics is crucial in wearable injector design for enhanced benefits, and consulting a materials specialist is recommended.

The Path Of Innovation In Modern Balloon Catheter Applications

Article | Nordson MEDICAL

Balloon catheters have a multitude of innovative applications today, including implantable balloons for weight loss, heat transfer balloons for induced hypothermia treatment, and more.

Introducing The MD Series: Medical-Grade Capacitors For Implantable Design

Article | Knowles Precision Devices DLI

The MD series of medical-grade capacitors is designed to meet MIL-SPEC standards, addressing the reliability needs of medical implantable devices.

Performance Test According To Chapter 2.1.7 Of The Ph. Eur.

Article | Sartorius

This operating procedure describes how to perform a repeatability and sensitivity test according to Chapter 2.1.7. of the European Pharmacopoeia.

Optimizing Outcomes Through Micromolding: An Expert Perspective

Article | Accumold

Craig Tappe, sales engineer at Accumold, highlights the micromolding process and emphasizes the significance of asking the right questions when selecting preferred suppliers.

Elements Of Design: Dealing With Suspect Parts

Article | Medbio

Automatically reject parts that do not meet key process parameter tolerances and cavity pressure curves in injection molding using automation.

Industrial Smart Components: What To Use When

White Paper | HID

The objective of this paper is to provide an overview of the current standard industrial HID Global RFID tag portfolio and provide a guideline of the RFID tag family’s main propositions.

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5 Key Factors To Gain Regulatory Approvals For Innovative Rapid Diagnostic Devices

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Phototherapy Devices: Where Is The Field Headed?

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Materials Innovation: Propelling A New Era For Medical Devices

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The Importance Of Software Validations For Medical Devices

RESOURCES