Preparing for MDR: Don’t Forget about Class I Reusable Devices

Posted by Britney Bartel, Marketing Manager on February 26, 2019

Medical device manufacturers are busy preparing for the about MDR and Class III device changes. As you work through your portfolio and sort your products into families, you’ll face many tough decisions. You need to be aware of some key changes to the regulations - 

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Topics: Regulatory, validation, Reprocessing, MDR, Class Ir, Reusable Device

MDR & ISO 10993-1: How to Navigate Preclinical Device Testing

Posted by Rachel Callender on February 19, 2019

Medical Design Briefs online recently featured an article written by Sandi Schaible, Senior Director of Analytical Chemistry and Regulatory Toxicology at WuXi AppTec, expert in re-writing ISO 10993-18 as part of TC 194 / Working Group 14.

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Topics: Contract Research Organization, Medical Device, Leachables, Preclinical Safety, Extractables, E & L, Regulatory, Regulatory Expertise, regulatory consultants, ISO 10993-1, MDR

ISO 10993-1: The Importance of Chemical Characterization

Posted by Rachel Callender on January 16, 2019

Think recent regulatory changes to ISO 10993-1 are impacting biocompatibility programs? Think again! Our Director of Analytical Chemistry, and International Delegate for ISO 10993 part 18, Sandi Schaible explains why chemical characterization should be the driver behind your biocompatibility testing plan.

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Topics: Contract Research Organization, Medical Device, Leachables, Preclinical Safety, Extractables, E & L, Regulatory, Regulatory Expertise, regulatory consultants, ISO 10993-1, MDR

A Regulatory Consultant's Guide to ISO 10993 Updates Webinar

Posted by Rachel Callender on January 15, 2019

With changes to ISO 10993, chemical testing is more important than ever to support a medical device’s safety for market. Medical device manufacturers can no longer rely on biocompatibility testing alone to obtain regulatory approval.

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Topics: Contract Research Organization, Medical Device, Leachables, Preclinical Safety, Extractables, E & L, Regulatory, Regulatory Expertise, regulatory consultants, ISO 10993-1, MDR

WuXi AppTec to Exhibit at DeviceTalks West, Costa Mesa, California

Posted by Rachel Callender on November 27, 2018

Visit the WuXi AppTec exhibitor booth #206 at DeviceTalks West, December 11-12, 2018, to learn how we work as a seamless extension of your team and develop a comprehensive program that will meet the endpoints you need to support your products’ safety.

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Topics: E & L, Regulatory, hemocompatibility, Technical Expertise, Regulatory Expertise, histopathology, regulatory consultants, ISO 10993-1, MDR

wuxi apptec to exhibit at devicetalks boston

Posted by Rachel Callender on October 04, 2018

Visit the WuXi AppTec exhibitor booth #513 at DeviceTalks Boston, which takes place Oct. 8-10, 2018. WuXi AppTec works as a seamless extension of your team to develop a comprehensive program that will meet the endpoints you need to support your product’s safety.

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Topics: E & L, Regulatory, hemocompatibility, Technical Expertise, Regulatory Expertise, histopathology, regulatory consultants, ISO 10993-1

Register Now for the PDA Chapter Dinner and Biocompatibility Presentation

Posted by Rachel Callender on September 17, 2018

WuXi AppTec Associate Director of Regulatory Toxicology Vanessa Haase, PhD, will present on biocompatibility testing as part of biological evaluation and ISO 10993.

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Topics: E & L, Regulatory, hemocompatibility, Technical Expertise, Regulatory Expertise, histopathology, regulatory consultants, ISO 10993-1

Helping Manufacturers Understand Product Bioburden Before Dose Setting

Posted by Jill Warren, Technical Specialist on July 16, 2018

To determine the best-suited dose-setting method, we first help manufacturers better understand product bioburden by employing the most effective testing methods and techniques.

We are equipped to support a broad range of products—from simple to complex, including complicated situations.

An advantage of partnering with WuXi AppTec is that we stay up-to-date on industry changes, and work with you to find the process that best fits your product needs.

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Topics: Medical Device, Regulatory, Technical Expertise, Microbiology, ISO 11737-1, Bioburden, Radiation Sterilization Validation

WuXi AppTec Attends FDA Workshop “Accreditation Scheme for Conformity Assessment (ASCA) of Medical Devices to FDA-Recognized Standards"

Posted by Yvonne Leonard, Director of Marketing on July 10, 2018

Our technical and regulatory experts actively participated in the workshop and its biocompatibility round table discussion.

The Federal Drug Administration (FDA) continues to focus on an approach to reduce the burden on medical device manufacturers with the goal to expedite time to market without jeopardizing regulatory oversight related to product safety. The agency’s latest program, Accreditation Scheme for Conformity Assessment (ASCA) of Medical Devices to FDA-Recognized Standards, was formed with this objective in mind.

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Topics: Medical Device, Biological Safety Testing, Regulatory, Scientific Director, biocompatibility, Technical Expertise

Important to Address the Stacked Effects of Soil Accumulation on Medical Devices

Posted by Dan Fowler, Principal Scientist on July 03, 2018

After each use of a medical device, soil may accumulate at a microscopic or macroscopic level that could potentially impede the terminal disinfection or sterilization process.

Over the course of a medical device’s life cycle, it may be used from one to many hundreds of times. For a reusable or third-party reprocessed product, it may be contaminated, cleaned and disinfected/sterilized multiple times throughout its clinical use.

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Topics: Medical Device, Regulatory, Technical Expertise, Reprocessing, Validation Study