Regulatory Wrap: Cybersecurity-Related Regulatory Considerations for Medical Devices

Regulatory and Biosafety Challenges for Vaccines

The global regulatory plan for vaccines provides a unique opportunity to develop safe and effective ones with assured quality. Methods used by regulators address challenges of new products and technologies and also increase understanding of benefits and risks of existing products. First, the laboratory-based regulatory sciences evolve correlates of immunity and safety; or improve the product ch...

Modeling Basel Regulatory in DSGE with Emphasis on Adequacy Regulatory

In this paper Basel regulation is modeled in Dynamic Stochastic General Equilibrium (DSGE) framework. For this purpose, using data from 1981-2017 for Iran, capital adequacy as an importance regulation is modeled. Results show Basel regulation has procyclical effect. According to the results of the model and according to the realities of economy and banking system of Iran, in recession, lending ...

Regulatory approval of new medical devices: cross sectional study

OBJECTIVE  To investigate the regulatory approval of new medical devices. DESIGN  Cross sectional study of new medical devices reported in the biomedical literature. DATA SOURCES  PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval. ELIGIBILI...

Cybersecurity and medical devices: A practical guide for cardiac electrophysiologists

Medical devices increasingly depend on software. While this expands the ability of devices to perform key therapeutic and diagnostic functions, reliance on software inevitably causes exposure to hazards of security vulnerabilities. This article uses a recent high-profile case example to outline a proactive approach to security awareness that incorporates a scientific, risk-based analysis of sec...

Regulatory Considerations for Nanopesticides and Veterinary Nanomedicines