Yvonne Leonard, Director of Marketing

Recent Posts

Limited Space, Register Now for two SEMINARS. day 1: ISO 10993 Case Studies and day 2: dissecting the changes of iso 10993 part 18.

Posted by Yvonne Leonard, Director of Marketing on July 31, 2018

Join WuXi AppTec’s technical and regulatory experts as we share our experience with ISO 10993 and what that guidance means for today’s medical device manufacturers.

On the first day, our team will share case studies regarding how Global Regulatory bodies currently interpret the guidance. As part of the working groups, our team will also share the upcoming changes to ISO 10993 parts 1, 17 and 18 and what those changes may mean moving forward for medical device manufacturers.

The second day is a deep this deep-dive into ISO 10993 Part 18. Sandi Schaible will look at the upcoming changes to ISO 10993 part 18 and what they may mean to chemical characterization test plans in the future. 

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Topics: Medical Device, Preclinical Safety, Technical Expertise, Regulatory Expertise, histopathology, regulatory consultants

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

WuXi AppTec Names Tim Drain as Director of Sales

Posted by Yvonne Leonard, Director of Marketing on June 12, 2018

WuXi AppTec is pleased to announce that Tim Drain has accepted the position of Director of Sales for the Laboratory Testing Division Medical Device Platform.

Tim has had an impressive career forged in the medical device industry with significant success leading multiple sales teams and achieving award-winning sales performance.

In a highly competitive market, much of his career was at one of our most important customers, Medtronic, where he was recognized with several honors for outstanding market share increase, leadership, strategy and sales training. Some of these awards were achieved during times of significant market challenges, which underscores his depth of leadership when it matters most.

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Topics: Medical Device, Regulatory, Technical Expertise

A Risk-Based Approach to Medical Device Testing Starts with Extractables and Leachables

Posted by Yvonne Leonard, Director of Marketing on June 05, 2018

As industry and regulatory bodies adopt the ISO 10993 Risk-Based Approach to Biological Evaluations, the demand for materials characterization studies increases.

And just as materials characterization plays a role in device design and development, extractables and leachables studies play a role in regulatory submission and preclinical safety testing.

WuXi AppTec works with you to first determine the best analytical approach for your medical device. We help you determine testing parameters, based on the device’s classification and indication for use (such as the intended population, route of administration and clinical application).

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Topics: Medical Device, Leachables, Preclinical Safety, Extractables, Biological Safety Testing, Regulatory, consultant, Technical Expertise

WuXi AppTec Names Mark Cunningham as Senior Director of Science and Technology

Posted by Yvonne Leonard, Director of Marketing on May 29, 2018

WuXi AppTec is pleased to announce that Mark Cunningham, Ph.D., has accepted the position of Senior Director of Science and Technology.

Dr. Cunningham brings more than 25 years of experience in the biopharmaceutical and contract research organization (CRO) industries supporting the R&D of pharmaceutical, biotech, medical device and combination products.

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Topics: Contract Research Organization, Medical Device, Preclinical Safety, Biological Safety Testing, Regulatory, Scientific Director, consultant, Technical Expertise

Wuxi AppTec Provides Wide Range of Consulting Services

Posted by Yvonne Leonard, Director of Marketing on May 15, 2018

Depend on the Industry Expertise and Broad Knowledge Base of WuXi AppTec’s Consulting Services

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Topics: Regulatory, FDA, consultant

WuXi AppTec Names former FDA Commissioner’s fellow as a Senior Scientific Director

Posted by Yvonne Leonard, Director of Marketing on May 01, 2018

We are pleased to announce that Li Yang, Ph.D., DABT, has joined our team as a Senior Scientific Director in WuXi AppTec Laboratory Testing Division’s Medical Device Consulting Group.

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Topics: Regulatory, FDA, Scientific Director, consultant

Q1 Productions 8th Annual Packaging Conference

Posted by Yvonne Leonard, Director of Marketing on April 30, 2018

WuXi AppTec is proud to be a sponsor at Q1 Productions’ 8th Annual Medical Device Packaging Conference, May 15-16, 2018, in Chicago, Illinois.

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Topics: Medical Device, package testing, package design, validation