One-Stop Shop for Tissue-Based Products

Our Medical Device Contract Manufacturing with AATB Accreditation and ISO 13485 Certification offers manufacturing and assembly expertise for multiple tissues and tissue-based products, whether in pursuit of the 361 or 351 regulatory pathway.

In addition to our testing expertise, the team at WuXi AppTec recognizes many of your pain points when it comes to tissue manufacturing, too, and we have solutions. Our manufacturing and testing teams collaborate to offer you a turn-key solution.

Read More

Topics: Medical Device, Technical Expertise, Contract Manufacturing, AATB Accreditation, Aseptic Technique

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.

Read More

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.

Read More

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, Principle 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.

Read More

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

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.

Read More

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).

Read More

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.

Read More

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

WuXi AppTec Offers PTT Testing with BFT II Analysis

Posted by Jean Kringstad, Director In Vitro Services on May 22, 2018

Recently, the FDA has questioned partial thromboplastin time (PTT) that has been run on a Cascade M-4 analyzer. The FDA has concerns about the equipment’s accuracy and sensitivity, and has indicated a preference for results from a BFT II analyzer. A backlog of PTT testing has resulted since many labs do not offer BFT II analysis.

Read More

Topics: Medical Device, Preclinical Safety, Biological Safety Testing, Regulatory, FDA, biocompatibility, hemocompatibility

WuXi AppTec to Exhibit at DeviceTalks Minnesota

Posted by Britney Bartel, Marketing Manager on May 17, 2018

WuXi AppTec will be an exhibitor at DeviceTalks Minnesota, June 4-5, 2018, in St. Paul, Minnesota.

DeviceTalks showcases the latest information on clinical trials, regulatory, technology and the medical device industry ecosystem.

Visit the WuXi AppTec exhibitor booth, #306, and connect with one of our many representatives. We anticipate lively discussions and fresh perspectives on the success, obstacles and future direction of the medical device industry. We also look forward to participating in the conference’s Clinical, Regulatory, Technology and Ecosystem tracks.

Read More

Topics: Medical Device, Preclinical Safety

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

Read More

Topics: Regulatory, FDA, consultant