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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...
Class II Medical Device Verification and Validation: What Goes into it?
Understanding Medical Device Verification and Validation When it comes to ensuring the safety and efficacy of medical devices, rigorous processes are in place...
Medical Device Industry Trends to Watch
Medical Device Industry Trends for 2024 and Beyond The medical device industry is constantly evolving, driven by advancements in technology, changing...
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?
What to Look for in Medical Device Component Manufacturers
Quality Medical Devices Start with a Quality Manufacturer Medical device component manufacturers are the backbone of your Class II medical device operation....
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...
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...