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EPA Announces Proposed Rules To Reduce Ethylene Oxide Exposure

Leave a Comment / AdvaMed, ethylene oxide, Medical Device, medical device strilization, MedTech, Quality/Regulatory, RC - Medtech Regulatory Resource Center, regulation, worker safety / By

EPA Announces Proposed Rules To Reduce Ethylene Oxide Exposure     On April 11, the Environmental Protection Agency (EPA) proposed new health protections to reduce exposure to Ethylene Oxide (EtO). These include a proposed rule regulating ethylene oxide (EtO) sterilizers of medical technology and other commercial uses through the National Emission Standards for Hazardous Air Pollutants …

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Blockchain Can Solve Pharma’s Costly Data Integrity Problem

Leave a Comment / blockchain, data integrity, legacy systems, Medical Device, MedTech, quality management, Quality/Regulatory, RC - Logistics Solutions Center, regulation, Soapbox / By

Blockchain Can Solve Pharma’s Costly Data Integrity Problem     In the pharmaceutical industry, quality data is the oil that keeps our systems running smoothly. In an increasingly digital world, the complexity of our data has grown exponentially, and, consequently, maintaining its integrity is an ever-growing concern. In fact, poor data quality costs companies $15 million …

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Connected Care: Overcoming Roadblocks and Identifying Opportunities

Leave a Comment / AFDO, AI, connected care, connectivity, data, Digital Health, From The Editor's Desk, Hologic, machine learning, Manufacturing Execution, Medical Device, MedTech, Orthogonal, Product Design & Development, regulation, Vicarious Surgical / By

Connected Care: Overcoming Roadblocks and Identifying Opportunities     What’s next—and what’s holding us back—on the road to a truly connected healthcare system? On March 14-15, leaders in digital health will come together at the ConnectedCare Summit East in Washington, DC, to look at best practices, pitfalls and what we’ve learned so far on the road …

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Tackling Go-To-Market Challenges

Leave a Comment / Design, health authorities, Medical Device, MedTech, Product Design & Development, Quality/Regulatory, registration pathways, regulation, scope, Soapbox, submission requirements / By

Tackling Go-To-Market Challenges     The medical device industry is amid an era of unprecedented regulatory complexity. Every 22 minutes, a new or updated regulatory requirement is issued somewhere in the world. All told, this amounts to 22,000 new or updated regulations every year, and it has led to a 150% increase in regulatory mandates over …

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