As a packaging professional in the healthcare industry, it’s important to understand the basics of adhesive coatings, including why they’re important, and their impact on packaging materials. A better understanding of adhesive coatings will help you design and troubleshoot your sterile barrier system. Pouches (Coated vs. Uncoated) There are tradeoffs when using coated and uncoated materials […]
Part 2: The 7 Common Mistakes made when picking a Package Design
May 23, 2022 by
In Part 1 , we discussed why not to procrastinate in your packaging design. The next step to protect your device and get it approved is to have a packaging expert take a look. Experts in ISO11607 can ensure that the material and design will meet or exceed your needs—and increase validation confidence. These are the […]
Part 1: It’s Only Packaging: What Could Possibly Go Wrong?
May 4, 2022 by
No medical device startup will hear any argument from us that the development of your device is Job One—as it should be. It is what drives you and your team, and if it goes well, that device could provide new care for the patients you’re trying to reach, while elevating your corporate and individual roles […]
Are Your Package Validation Requirements Ready for EU MDR?
June 25, 2020 by
The COVID-19 pandemic has affected us all these past few months and presented many new challenges for the medical device industry. For package testing, we have seen delays in getting samples shipped to our laboratories due to interruptions in the supply chain. Many MDMs also were forced to put some projects on hold due to […]
What Mass Testing Means for the Packaging World
June 1, 2020 by
As the world fights the COVID-19 pandemic, the tone in America has shifted since the initial battle cry to “flatten the curve.” The lockdown of schools and non-essential business has passed the 10-week mark and caused a counter-reaction to re-open businesses, states, and the overall economy. Short of a vaccine, many public health officials agree […]
Understanding the biological effects of medical packaging in the assessment of a medical device.
June 17, 2019 by
For many years Toxikon has been performing biocompatibility testing of medical devices. Biocompatibility testing is a risk/benefit approach in understanding the safety of a medical device or product. That process can be pretty simple, using the guidance of ISO 10993 and regulatory guidance for industry. Resources like ISO 10993-1 and the FDA’s guidance available today […]
Common Medical Device Packaging Mistakes
December 12, 2018 by
Medical device packaging is almost as important as the device itself. Packaging for medical devices plays a key role in safely delivering specialized treatment to patients. Most single use, sterilized medical devices can be opened with a high degree of confidence that it has remained sterile throughout storage, handling, and transportation. What makes medical device […]