Quality Medical Devices Start with a Quality Manufacturer Medical device component manufacturers are the backbone of your Class II medical device operation. Whether it’s a life-saving implant, a diagnostic instrument, or a sophisticated monitoring device, the quality...
Technical Expertise
What is the Class II Medical Device Design and Development Process?
Innovation plays a pivotal role in enhancing patient care, diagnostics, and treatment outcomes. One critical aspect of this innovation is the design and development of Class II medical devices. This process involves a variety of stages, ensuring the final product...
Safe & Compliant: Mitigating Risks After Device Modifications
The medical device regulatory environment is continuously evolving. As regulatory body expectations become more demanding, manufacturers need to evaluate the safety implications of changes to their devices and processes. Manufacturing modifications are one example...
Planning and Predicting for ISO 10993: Part 18 & Part 17
Regulations published by the International Standards Organization (ISO) provide a global structure for the medical device industry. These standards can affect development timelines for new products and, in some cases, can influence which products a company can keep on...
In the News: Readying Reprocessed Devices
Writing cleaning instructions for reprocessed medical devices can pose unique challenges during IFU development, but it is critical to get it right the first time. In a recent article for MedTech Intelligence, WuXi AppTec Principal Scientist Dan Fowler dives into...
Responding to Regulatory Requests for Additional Information
There's been a significant increase in the prevalence of requests for additional information in recent months, particularly following ISO 10993-18:2020. Collaborating on these responses is the best way to deliver quality answers promptly, and WuXi AppTec Medical...
Developing Cleaning Methods for Successful Validation
When it comes to reusable devices, one of the many requirements in medical device development is providing detailed directions of the cleaning methods defined in the Instructions for Use (IFU). Validating those cleaning methods may seem to be a box to check before...
TRA of Medical Devices & Proposed Updates to 10993-17
In cases where biocompatibility testing may not entirely mitigate medical device risk, chemical characterization data has become increasingly important. The updates to ISO 10993-18:2020 are applying pressure to supply sufficient chemistry data, meaning the industry...
AATCC TM 100-2019: Assessment of & What It Means for Medical Textiles
Staying up to date on regulatory requirements and industry standards can be a challenge with ever-evolving expectations. However, keeping a close eye on changes in standards will insure that your medical device testing stays on track to a successful submission. Today,...
Maximizing Your Lab Partnership: Details Pay Dividends
Have you ever wondered “why do labs ask for so much information?” Or “how can we speed up this testing process?” Those two questions actually have a lot to do with each other. The devil is in the detail. Labs need to ask a lot of questions about your device to be able...
White Paper: Unknowns are Unacceptable™
Unknowns are Unacceptable explains our risk-based approach to medical device chemical characterization and toxicological risk assessment.