The partnership brings together Evidence Partners’ literature review platform, DistillerSR, and Akra Team’s strategic regulatory services.
Manufacturers preparing premarket submissions should provide performance specifications for the quantitative imaging functions, supporting performance data, and sufficient information for the end user to obtain, understand and interpret the values provided.
Old justifications or business reasons for security gaps are obsolesced. We need robust medical device cybersecurity, but we need it in a manner that is workable by both MDMs and HDOs.
“Approaches to Increasing Diversity in Clinical Research and Addressing Health Inequities” offers key recommendations for device manufacturers and developers on steps they can take to increase diversity in clinical research and address health equity.
An analysis of the HVAD pump implant kit showed moisture had entered the center post of the pump causing corrosion and demagnetization of the internal magnets, which may cause the pump to rotate incorrectly.
Inaccurate data entry, discomfort and privacy concerns are among the issues that developers and designers must address to realize the promise of medical wearables.
The upcoming revision to ISO 10993-17 proposes the use of release kinetics data to support toxicological risk assessments. Manufacturers should expect that this data will be needed to help mitigate the risks identified in exhaustive extraction studies.
Rapid developments in healthcare technology, combined with improved data collection, pandemic pressures and increased consumer demand for tech-enabled and virtual health care, are fueling innovation and transformation in the digital health space.
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
“The MedAccred Labeling, Printing and UDI Task Group’s role is to provide medical device companies with structure and requirements to assist in identifying and implementing industry best practices for global market compliance.”