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

Our All-Inclusive Approach to Microbial Identification

Posted by Elizabeth Fassinger, General Microbiology Manager on December 11, 2018

WuXi AppTec’s robust approach to microbial identification (ID) testing surpasses the industry standard offered by other laboratories.

Our clients come to us when a microbial excursion has occurred. Understanding what the microbial contaminants are, and where they have been introduced into the manufacturing process, is critical in determining the root cause of the microbial excursion, as well as effective corrective actions to prevent re-occurrence.  

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Topics: Medical Device, Technical Expertise, Microbiology, Microbial Identification

Environmental Monitoring Supports a Risk-Based Approach to Manufacturing Control

Posted by Richard Nardini, Environmental Services Manager on December 04, 2018

Robust Environmental Monitoring Program includes information to support process controls through sample collection, microbial testing and trending data. 

Environmental monitoring is one way a device manufacturer demonstrates control within a production area. Environmental samples from water, air and surfaces support verification of process controls and ultimately support product safety. Trending this valuable data offers manufacturers a qualitative indicator of the cleanliness and controls within their production areas.

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Topics: Medical Device, Technical Expertise, Microbiology

Radiation Sterilization: Verifying Dose Survivors

A wealth of knowledge was gained from a historic data review of radiation dose verification failures. Our experts highlight the importance and application of this data set as well as its benefit to device manufacturers. 

In last week’s blog post, we highlighted the importance of bioburden monitoring, both quantitatively and qualitatively, as supportive evidence for a valid radiation dose. We arrived at this conclusion through a historic data review of verification dose experiments.

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

Radiation Sterilization: Product Bioburden and Verification Dose

WuXi AppTec supports the best practice of monitoring bioburden quantitatively and qualitatively to ensure the established radiation dose is valid.

For many medical device manufacturers, radiation sterilization is a critical element of sterility assurance programs. ISO 11137-1, ISO 11137-2 and ISO TS 13004 specify the requirements for establishing a sterilization dose based on known product bioburden, including quantity and resistance.

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

Product Adoption for Sterilization Validation

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

When your product has had a material change, a component added, or a new size developed, does this necessarily mean you must complete the sterilization validation of each?

There is another option:  product adoption.

WuXi AppTec Technical Experts answer common questions about product adoption when completing a sterilization validation.  The question to be answered is - whether or not to validate independently or adopt into a family?

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Topics: Medical Device, Technical Expertise, Bioburden, Regulatory Expertise, Sterilization Validation

Poor Extraction Methods Can Impact Study Results

Posted by Dan Fowler, Principal Scientist on October 09, 2018

When planning a cleaning validation study for your medical device, a validated extraction method is one requirement.

The purpose of an extraction process is to recover any residual soils from the medical device or testing substrate and then quantify those residuals for specific test markers such as protein, hemoglobin or carbohydrates.

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

WuXi AppTec Technical Experts at the American Association of Tissue Banks Expo, Booth #49

Posted by Britney Bartel, Marketing Manager on September 18, 2018

WuXi AppTec, a longtime member of the AATB, returns for the 42nd Annual Meeting, October 9-12, 2018.

The AATB annual meeting, held in Dallas, Texas, this year, encompasses a vast array of continuing education classes, breakout sessions and an expo. The meeting brings together suppliers, manufacturers and end users within the tissue-product ecosystem.

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Topics: Medical Device, Technical Expertise, Contract Manufacturing, AATB Accreditation, Aseptic Technique, Regulatory Expertise, ISO 10993-1