Well-designed training maximizes learner retention and understanding, and focuses on the information needed for safe and successful use. It also is important to understand that training for purposes of risk management cannot prop up a poorly designed device.
Advances in the technology that enables production of 3D-printed medical devices continues to outpace development of the regulations, standards, and best practices intended to guide design and delivery of such devices. Learn how to insulate yourself from the resultant legal, regulatory, and business risks.
Writing effective IQ/OQ/PQ protocols is a must for following the regulations required by the FDA for equipment, systems, and utilities to demonstrate suitability for the intended use.
Executives throughout business often misunderstand the meaning of developing business. Business development is about the “long game.” It’s about developing opportunities and collaborations over the longer term, while solidifying and expanding current customer relationships.
The “messy, getting started” period in pre-product development can make many development teams and life science organizations uncomfortable – until you recognize “fuzzy” as less of a warning, and more of an invitation.
The Medical Device Single Audit Program (MDSAP) is recognized by officially approved Auditing Organizations (ISO Registrars) to conduct a single regulatory audit, of a medical device manufacturer, that satisfies relevant requirements of the regulatory authorities participating in the program.
Latin America is developing into a sizable, predictable part of the global medical device market, allowing foreign manufacturers to have sustainable commercial operations.
This article explores the adoption of intracranial stenting across three major markets (U.S., Germany, South Korea) and projects the overall market opportunity according to currently approved indications.
India’s federal government recently announced a plan to offer free medical insurance to over 500 million of its poorest citizens. Astute medical device companies can leverage this opportunity to build new businesses while transforming the lives of millions of families who presently lack access to the most basic procedures.
The propulsive force driving AI development is the developed world’s aging population, facing growing incidences of chronic illness and morbidity, combined with unsustainable healthcare spending in dire need of curtailing.
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