The expansion of its talent acquisition team was a strategic decision that will ensure the continued value and success that Medpoint provides its customers with.(Greenville, SC) Medpoint, LLC, experts in Quality, Regulatory, and Clinical Affairs talent acquisition and professional services, announced today the addition of two certified healthcare recruiters to their talent acquisition team. These... Read More

In the rapidly evolving realm of medical technology, a major focus must be maintained regarding patient safety and product quality. As leaders in the MedTech industry, it is imperative to put processes and systems in place to ensure vigilance around potential risks -- and proactively implement measures to address them. Sometimes, however, issues identified post-market result in product recalls.... Read More

GREENVILLE, S.C. July 13, 2023 | Medpoint, LLC, experts in Quality Assurance, Medical Regulatory Consulting, and Clinical Affairs Consulting, announced today that they have secured a substantial increase in QMS auditing capacity in both Japan and China. The additional bandwidth in Japan and China will provide more scheduling flexibility and shorter lead times throughout the Asia Pac medical... Read More

In March and April 2020, the Food and Drug Administration (FDA) issued guidance aimed at expanding the availability of certain medical devices that were critical in fighting COVID-19, such as ventilators, respiratory devices, sterilizers, disinfectants devices, air purifiers, gowns, hoods, and gloves. The guidance, which would remain in effect only for the duration of the pandemic public health... Read More

Due to the limitations inflicted by the pandemic, Remote Interactive Evaluations (RIEs) are becoming an important part of regulatory decision-making. Specifically, the FDA is using RIEs to limit unnecessary contact. Read More

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Since the start of the COVID-19 pandemic, the FDA has had to adjust its approach to in-person inspections. The agency is now taking advantage of the available technologies to maintain high-level regulatory oversight remotely. Read More

The medical device industry is already feeling the effects of the Artificial Intelligence (AI) revolution. However, most advanced AI algorithms are not well-suited for the current regulatory landscape. Fortunately, the FDA has released an actionplan on how they plan to handle the challenges brought on by AI/ML-based software for medical devices. Read More

When contracting with external experts, you may be uncertain about whether to select a consulting firm or work with an individual consultant, i.e. a single-person LLC or sole proprietorship. Read More

When it comes to ensuring compliance and avoiding FDA warning letters, regulatory affairs consultants are an excellent option. Choosing the right consultant can help your organization avoid compliance problems and improvethe time-to-market for your product. Read More