be prepared GettyImages-1400534401 Breeze Through Surprise Audits — Take These 5 Actions Now

Summer is here! That means you might hear the dreaded words, “Surprise! We are coming to audit you!” Whether it’s a client, supplier, or regulatory agency calling for an audit, those words can strike fear in even the most organized companies. But not if you're prepared by taking these five action items now.

  • The FDA's proposed update to the Quality System Regulation that was originally released in 1996 references ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, which is in its third edition. Let's take a closer look.

  • This article provides an overview on the five types of neuromodulation devices: spinal cord stimulation, deep brain stimulation, sacral nerve stimulation, vagus nerve stimulation, and gastric electric stimulation, as well as related market trends.

  • In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.


  • Benefits Of RFID For Medical Device OEMs

    This guide will examine why OEMs are increasingly turning to integrated RFID to add value to their products in an increasingly crowded marketplace, and provide key applications for RFID in the medical device field.

RFID For Med Devices: Identifying A Partner

RFID is increasingly being used in medical devices. OEMs can either develop their own RFID solution or partner with an experienced supplier - this guide provides guidance on finding a suitable partner, including what to look for in a supplier, case studies, and proprietary technologies.

Transformative Shifts In Medical Device Package Quality Testing

While the medical device industry continues to evolve to accommodate lifesaving therapies, advancements in deterministic testing technologies ensure medical device packaging integrity and sterile delivery to the patient.

Advances In Piezo Mechanics Aid Eye Surgery

The article discusses recent advancements in piezo mechanics that are being utilized to improve precision and effectiveness in eye surgery procedures.

The Challenges Of Boomerang Projects In Micro Molding: A Customer Perspective

Boomerang projects in micro molding, where customers' projects return to the manufacturer for rework or modifications, present challenges due to design changes, quality issues, material-related challenges, and poor communication.


Flexan is committed to providing the highest quality of silicone components for medical devices. Using the highest process controls alongside the most rigorous quality tools, Flexan is able to ensure patient safety and 100 percent inspection of every single component before it ships.

B. Braun provides an array of parenteral pharmaceutical solutions, including those for use in standard IV, irrigation, nutrition, and anti-infective therapy applications. The EXCEL® and PAB® containers and the DUPLEX Drug Delivery Systems feature biologically inert, PVC-Free and DEHP-Free, non-toxic plastic construction for a safe and accurate method of administering IV medication.

Canon's brushless servomotors are compact in size and provide high output power. Two types are offered with quick response and smooth rotation. Various custom options can be incorporated to fit your applications.

As the global life expectancy continues to get longer, the demand for electronic medical implantable devices is growing. Knowles offers a variety of capacitor solutions for the medical implant industry.

DSM Biomedical delivers a versatile and tunable hydrophilic polymer technology designed for adhesive applications. This technology mimics the proteins of marine mussels when they bond to underwater surfaces.

Quick Time To Market, Significantly Lower Risk

Daikyo Crystal Zenith® Luer Lock syringes are designed to fit a variety of standard drug delivery devices, and compared to glass they offer unprecedented strength, durability, and protection.


Accumold® is a high-tech manufacturer of precision micro, small and lead frame injection molded plastic components

For the biopharmaceuticals industry, Sartorius offers a comprehensive, globally unique program of products and services, ranging from the discovery of active pharmaceutical ingredients to process engineering, from scale-up and production to compliance with regulatory steps.




Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.

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