Managing Testing Strategies Under the EU MDR
Companies can improve their chances for a successful transition by leveraging their knowledge of their medical devices and understanding what each device’s categorization under the MDR means to its testing strategy…….
Proposed Medical Devices Standard Will Help Validate Cleaning Methods
An ASTM committee is developing a series of guides for validating cleaning instructions for medical devices…….
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4 Steps for Error-Free Coding on Pharmaceutical Packages
Validation is a major component of pharmaceutical manufacturing, ranging from production systems, packaging equipment, and computer programs. The packaging printer is a critical element in the validation process……
Exceeding regulatory requirements: Beyond the checklist
Many manufacturers run into issues as they adjust their devices and testing plans to meet updated regulatory requirements. Using a risk-based approach to predict and mitigate risks can help prevent costly setbacks.
Medical Device Extractables and Leachables Testing in 2020
Chemistry for toxicology (ChemTox) testing has evolved considerably in the last couple years. Here’s what you should consider for your own program.
How to navigate testing for devices that use wireless technology
The Federal Communications Commission (FCC) has a different testing requirements for wireless medical devices than the FDA. Here are some tips of choosing a testing method for FCC compliance.
Implementing the IEC 60601-1 Medical Electrical Equipment Standard
Why a mobility classification matters and how to choose the right one.
The Pros and Cons of Standardized Testing
Is a standard test necessarily the right test?
Applying Quality Management Best Practices for Medtech
A look at how one medical device manufacturer automated quality management along with ideas on how shared intelligence can drive quality from the shop floor to the top floor.
Putting the ‘Management’ into Quality Management System
Three ways to demonstrate management oversight within your QMS.
