To fully realize the potential of bioelectronic medicine, medical device developers will need to find ways to move beyond "set and forget" biostimulation devices to closed-loop systems that can provide more responsive and personalized treatments.
In today’s high-stakes trade-off game, to be widely adopted, an advance must conclusively improve or extend human life while being cost-justified over the existing standard of care.
HFE testing, as a professional discipline, has not taken advantage of a wide range of advanced and well-understood physiological, biomechanical, cognitive, and emotional sensing and testing modalities.
The questions for manufacturers are, how many hurdles will they need to overcome to ensure compliance, and will the new regulations lead to some legacy products no longer entering the market?
To come out on top, some medical device companies are dedicating more attention to the workplace as a competitive differentiator. Investing in smart real estate and facilities strategies can pay dividends in helping companies win and retain the best talent. What’s working?
Knowing how to classify your device as either SR or NSR is not a clearly defined task. There are implications for each decision made as you proceed through development, and the burden is on you to understand and to provide what the FDA will require.
A more thoughtful approach to product R&D can help to minimize the gap that currently exists between those engaged in the actual practice of healthcare and those performing research, developing, and commercializing medical devices.
The organization’s QMS must have an overarching quality plan -- one that details the elements to be implemented to achieve a successful transition – and must work directly with all the stakeholders involved.
India’s Medical Device Rules, 2017 have many attractive features that encourage the medical device sector in India. They have been formulated to promote domestic manufacturing and to regulate import and manufacturing in the region. This article examines some of the regulation’s key points to provide a better understanding of its impacts.
This article presents the requirements regarding documentation of QMS procedures and work instructions and then introduces methods that can be used to effectively document compliant procedures.
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