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ISO 10993-1 Primer: Medical Device Testing for Risk Management
Planning a biological evaluation of your medical device? Then you need to be familiar with ISO 10993-1. This primer covers the fundamentals. The International...
Navigating European Medical Device Premarket Submissions
Navigating the tricky waters of regulation can be frustrating and challenging for any medical device manufacturer. When those regulations change, the prospect...
Overcoming Obstacles to Tissue Sterilization Validation: What Manufacturers Need to Know
Sterilization validation is necessary to bring tissue-based products to market. The U.S. FDA requires it, whether the device functions in vivo or in vitro, so...
The Critical Role Reprocessing Instructions Play in a Medical Device’s IFUs
Drafting Instructions for Use (IFUs) for medical devices is a delicate but critical task that supports patient safety. IFUs need to include detailed,...
Are You Prepared If Your Disinfectant Is Discontinued?
The U.S. EPA banned the active ingredient in a popular disinfectant in 2018. Would you know what to do if your go-to cleaning product was phased out?
Regulatory Development Indicates Shift Toward In Vitro
After several years of waiting, the International Organization for Standardization (ISO) approved the release of ISO 10993-23 in January 2021. The standard...
What to Ask Before Submitting Your Medical Device for Approval
Testing your medical device properly and preparing a strong regulatory submission is a dynamic yet crucial part of bringing the product to the market. Put...
Packaging Pitfalls Medical Device Manufacturers Cannot Ignore
As stated in the international packaging standard, ISO 11607, designing and developing a packaging system for terminally sterilized medical devices is a...
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...
E/L Testing Isn’t What It Used to Be
Medical device biological safety evaluations have advanced significantly over the last ten years, and regulatory requirements are quickly evolving as well....
3 Regulatory Red Flags with Medical Device Changes
Before modifying your medical device, consider how it could affect your testing plan and potentially put approvals at stake.
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...