Archive for the ‘Regulatory Medical Writing’ Category

Beautiful Reflection on Water House by a Lake

Clinical Evaluation Report (CER) Medical Writer

Perform Clinical Evaluations and write/update Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs)  in compliance with the European Union (EU) Medical Device Regulation (MDR).  Perform Literature Reviews using PubMed, Embase, Cochrane Library, and similar databases. Interpret the current, new, and changing requirements for clinical research—including heightened restrictions on product equivalency—to ensure the proper clinical […]

CMS Shared Savings Program

Background The Affordable Care Act (ACA) included provisions to expand value-based purchasing; broaden quality reporting; improve the level of performance feedback available to providers; and create incentives to enhance quality, improve beneficiary outcomes, and increase the value of care. Confidential physician feedback reporting was initially implemented under Section 131 of the Medicare Improvements for Patients […]

Declining incidence of major diseases: heart disease, hip fractures, colon cancer, etc.

“Screening, they say, is only part of the story. “The magnitude of the changes alone suggests that other factors must be involved,” they wrote. None of the studies showing the effect of increased screening for colon cancer have indicated a 50 percent reduction in mortality, they wrote, “nor have trials for screening for any type […]