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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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Bathrooms “R” Us

Physician's Practice

Reynolds Blog Article The small details, like restroom cleanliness, shape patient perceptions and impact healthcare experiences in practices. This may cause you to question the airline’s attention to details like engine maintenance or losing passenger’s luggage. A clean bathroom goes unnoticed because it’s expected. But a dirty one?

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New South Family Medicine and MedSpa Offers Next Level Care

New South Family Medicine and MedSpa

Providers at New South Family Medicine and MedSpa can address the patient's deeper needs, rather than trying to rush through a hectic day full of too-brief appointments. You can continue to use your insurance for medications and for labs as well. Instead, they establish a direct patient-provider relationship, for a flat fee.

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Do You Hear What I Hear? One Year of OTC Hearing Aids

FDA Law Blog

The rule established a new category of OTC hearing aids for individuals with mild to moderate hearing loss, allowing them to purchase hearing aids directly from stores or online retailers without the need for a medical examination, prescription, or fitting adjustment by an audiologist. In some measurable ways, the rule has been a success.