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Regulatory Changes

Proven track record

From biological evaluation to microbiological testing, our robust approach and expertise ensure a complete data package. For us, Unknowns are Unacceptable™. See why WuXi AppTec is the Contract Research Organization (CRO) that can function as an extension of your team and be a strategic partner—with proven submission success that saves you time and money.

Shared Knowledge: Our Expertise is Yours

We understand recent regulatory changes, and can help you make sense of how they impact you.

Understanding changes to ISO 10993

The most recent changes to ISO 10993-1 make chemical characterization the driver behind your biocompatibility testing plan. A comprehensive risk assessment relies on complete chemical characterization. Calculating the margin of safety for each and every chemical in the chemistry report supports the safety of your device. WuXi AppTec’s program is the only one built around complete identification.

Expert insight

Additionally, WuXi AppTec’s Senior Director of Analytical Chemistry and Regulatory Toxicology, Sandi Schaible, serves as an international delegate for ISO 10993 Part 18, giving our team unique insight into how to maneuver the recent changes, and what to expect moving forward.

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Partnering on MDR changes

Perspective is important when it comes to understanding the recent changes to the European Union Medical Device Regulation (MDR). WuXi AppTec is fully up to date on what the MDR changes are, and how to keep you ahead of them.

Expanded facilities

While the testing requirements are nothing new, manufacturers need to understand which products they’re going to register and how they’re going to prioritize their approach. Lab capacity is also becoming scarce, so you want the right analytical partner that can ensure your study isn’t full of unknowns that would waste precious time—and money. You want to test right the first time to avoid any submission delays, which is why we expanded our facilities to accommodate your needs.

Your decision-making team

Whether you’re viewing the updates from a regulatory or financial impact lens, you need a cross-functional team that includes procurement, manufacturing, quality, regulatory, product management, research and development, preclinical, finance, sales, and strategic contracting.

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