New technologies, process advancements and the aging population have all led to explosive growth within the medical device industry. This growth has also led to more strict and complex regulations with increased competition. The rising regulatory focus and increasing demand for high quality and standard products across the medical device industry has also driven the […]
Matching Your Penetration Tester to Your Medical Device Cybersecurity Program
March 28, 2023 by
What is a Penetration Test? Free-form security testing, or penetration testing (often called pen testing), is a minimally structured examination of the cybersecurity for a target device or system. For those familiar with requirements-based verification and validation (V&V) testing, penetration testing is different altogether. The intent of penetration testing is to find unknown security vulnerabilities […]
3 Package Testing Methods to Ensure the Quality of your Product
February 17, 2022 by
There are many ways to test your package or pouch for imperfections. Each method provides a unique output and can help identify crucial data for improving your finished package. We asked our Project Engineering Manager, Brian Nissen, to highlight 3 testing methods commonly used for medical device packaging. 1) Tensile Testing Tensile testing is used […]
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 […]
Why the R&D Group Need Not Fear the Package and Distribution Lab When Developing an Injectable Biologic Product
July 15, 2019 by
A recent FDA Guidance document titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations” outlines recommendations on the design and evaluation of comparative analytical studies intended to support a therapeutic protein product. This includes conducting an appropriate physicochemical and functional comparison of the stability profile of the proposed product, accelerated and stress stability […]