Blog
Benefits of Class II Medical Device Contract Manufacturing
Partnering with a Class II Medical Device Manufacturing Company Saves Time and Money Class II medical device manufacturing requires precision,...
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...
Understanding Medical Device Conceptualization and Research
A Guide to Medical Device Conceptualization and Research Do you have an idea for a Class II medical device, but you’re not sure where to start? You’re not...
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....
The Complete Guide to Class II Medical Device Development
The Step-by-Step Guide to Creating a Life-Changing Class II Medical Device Navigating the Class II medical device development process can be overwhelming....
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...
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...
Preparing for a Pre-Submission Meeting En Route to Regulatory Approval
The current regulatory environment has created opportunities and setbacks for medical device companies as they work toward obtaining regulatory approval on...