Resource Center

Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.

COVID-19 and the FDA: What Every Manufacturing Company Needs to Know

COVID-19 and the FDA: What Every Manufacturing Company Needs to Know

Are you a manufacturer and want to help with the COVID-19 Pandemic? We invite you to attend our upcoming webinar to learn more about FDA’s temporary policies for regulating Personal Protective Equipment (PPE), Reprocessing, Ventilators and Hand Sanitizer manufacturing, and what you need to do to get your product on the market.
Building a QMS for Your SaMD

Building a QMS for Your SaMD

Our Lead Quality Engineer, Nikita Angane, explains how to build a strong Quality Management System for your Software as a Medical Device.
Medical Device Product Development

Medical Device Product Development

Our Quality Engineer, Madison Wheeler, discusses the characteristics of an efficient product development process for medical devices and how medical device product development should incorporate Quality, Regulatory, and Business needs in parallel.
COVID-19 Impact on the EU MDR

COVID-19 Impact on the EU MDR

With the COVID-19 pandemic halting life as many know it globally, the May 26th EU MDR deadline still looms over the

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