Effectively conducting a uFMEA not only facilitates correct identification of existing usage risk, it aids in the generation of crucial design updates for risk reduction or elimination.
On Sept. 6, 2018, FDA announced the launch of a new pilot 510(k) program. This initiative, the Quality in 510(k) “Quik” Review Program Pilot, proposes an alternate pathway to regulatory submission and approval for medical devices. Quik is in its early stages and is therefore limited in scope, but it nonetheless offers another approach to premarket notification. This article examines what makes Quik different from traditional 510(k) submissions, plus its benefits and challenges for medical device manufacturers.
Data integrity is essential in the pharma, biologics, and medical device manufacturing industries. Not only is complete, accurate, and reliable data necessary to assure drug safety and quality, the growing reliance on increasingly sophisticated digital systems means that issues relating to data integrity are increasingly complex.
Just two percent of the revenues generated by the top 200 medical device companies arise from emerging markets. To achieve greater success, medtech must look beyond the legacy approaches that led to success serving the billion richest patients in the world.
Despite a labyrinth of risks to overcome, the Mexican medical device market is primed for growth, and presents tremendous opportunity to medtechs that can navigate its pitfalls.
A refreshed approach to fault tree analysis can be an incredibly helpful addition to your problem-solving armamentarium. Having the confidence to begin using it — or begin using it more often — is the first step toward getting more comfortable with it and mastering its effects and nuances.
Despite the CER being a critical compliance element for medtechs doing business in the EU, there continues to be significant lack of clarity regarding key requirements and best practices for creating these reports.
As China’s National Medical Products Administration nears finalization of its 2018 draft Amendments to the Regulations on the Supervision and Administration of Medical Devices, medical device companies should understand the impact these changes will have on the global medical device market.
Getting to this point has been a multi-year progression of technological development and regulatory evolution by both the market and government.
During a recent meeting of data integrity professionals, a fundamental question was posed by a member of the group: “How can one prevent or detect malicious intent as it relates to changes to information and the impact to data integrity?”
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