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.

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

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.

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

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.

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

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

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?

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

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.

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

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.

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

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.

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

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

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

Associate Director of Regulatory Toxicology, Dr. Vanessa Haase, will present the case study at the Q1 Productions Medical Device Sterilization conference on September 24, 2018.

The most recent version of ISO 10993 Part 1, published in August 2018, emphasizes the need for biological evaluations to begin with chemical characterization. In this case study, Dr. Haase outlines a risk-based approach to device preclinical safety in accordance with ISO 10993. The case study, which features a blood-contacting device, summarizes chemical characterization, toxicological risk assessment and a biocompatibility test strategy for evaluating the relevant biological end points. Dr. Haase will speak at 11:15 am on September 24.

Topics: Medical Device, Technical Expertise, Regulatory Expertise, ISO 10993-1