Sterilization Validation 101: What's Required, How Long It Takes, and How to Plan for It
Ethylene oxide sterilization validation is often treated as a final step, but it's actually a multi phase program with real lead times, starting with bioburden testing and ending with a validated PQ. This guide breaks down the IQ, OQ, and PQ phases, typical timelines, and where validation programs commonly slip, so it doesn't become the bottleneck standing between your device and the market.
Marie O’Malley to Speak on Manufacturing Tradeoffs Panel at MPP West 2026
PiSA USA’s Chief Commercial Officer, Marie O’Malley, will take the stage at MPP West 2026 to discuss one of MedTech’s biggest challenges—balancing cost, speed, and compliance. Joining industry leaders, she’ll share real-world insights on navigating manufacturing tradeoffs and scaling efficiently in today’s complex regulatory landscape.
From Pilot to Scale-Up: Navigating the Transition to Commercial Manufacturing with a CMO Partner
Transitioning from pilot to commercial manufacturing is one of the most critical phases in product development. This guide breaks down the key challenges, validation requirements, and strategies companies need to scale efficiently with the support of an experienced CMO.
PiSA USA’s Marie O’Malley to Speak at The Future of Sterilization Workshop at MD&M West 2026
PiSA USA announced that Marie O’Malley, Chief Commercial Officer, will speak at The Future of Sterilization Workshop at MD&M West 2026 in Anaheim, California. The session will explore emerging sterilization technologies, regulatory considerations, and strategic implementation approaches for medical device and pharmaceutical manufacturers, highlighting PiSA USA and Centerpiece’s expertise in advanced sterilization, compliance, and supply chain solutions.
ETO vs. Irradiation, Autoclave, and Emerging Sterilization Methods: Choosing the Right Approach for Your Medical Device
Selecting the right sterilization method is one of the most critical decisions in medical device manufacturing. From ETO to irradiation, autoclave, and emerging modalities like chlorine dioxide and X-ray, each technology offers unique advantages and limitations. This article explores how ethylene oxide (ETO) continues to set the standard for complex and heat-sensitive devices—while comparing it to other leading sterilization methods in terms of compatibility, efficiency, and scalability.
PiSA USA’s Marie O’Malley to Join MassMEDIC Fireside Chat on Technology Challenges in MedTech
PiSA USA is excited to share that Marie O’Malley, Vice President of Commercial Operations, will be a featured speaker at MEDevice Boston 2025. O’Malley will join MassMEDIC’s Fireside Chat: Breaking Barriers — Leading Through Technology Challenges in MedTech on October 1, 2025, bringing nearly 30 years of industry expertise to the stage. Known for her leadership in innovation, supply chain, and regulatory compliance, O’Malley will discuss how collaboration and forward-thinking strategies can turn technology challenges into opportunities for safer, more sustainable solutions.