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 - 

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

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

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.  

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

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.

Topics: Medical Device, Technical Expertise, Microbiology

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

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.

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

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.

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

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