Pictures shot by Heather Cox Richardson while kayaking.
Archive for the ‘Regulatory Medical Writing’ Category
Clinical Evaluation Report (CER) Medical Writer
Posted by Michael A. S. Guth on March 15th, 2020
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 […]
Posted in Featured, Regulatory Medical Writing 
Comments Off on Clinical Evaluation Report (CER) Medical WriterCMS Shared Savings Program
Posted by Michael A. S. Guth on October 20th, 2018
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 […]
Posted in Featured, Regulatory Medical Writing 
Tags: accountable care organization, CMS, Medicare, physician fee schedule, risk sharing, shared savings program Comments Off on CMS Shared Savings ProgramDeclining incidence of major diseases: heart disease, hip fractures, colon cancer, etc.
Posted by Michael A. S. Guth on October 18th, 2018
“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 […]
Posted in Featured, Regulatory Medical Writing Comments Off on Declining incidence of major diseases: heart disease, hip fractures, colon cancer, etc.
