Skip to main content

Popular posts from this blog

ISO Management Standards for Medical Devices

Two main ISO standards that have a direct application to Medical Device Industry are ISO 9001 and ISO 13485. While ISO 9001 is for evolving a Quality Management System for an organization, ISO 13485 has a direct application to Medical Device Industry. Although, ISO standards for a company are not a legal requirement, but provide a validation and ease of global marketing of the product.
1 comment
Read more

FDA Launches Medical Device and Radiation-Emitting Product Transparency Web Site

BayBiotech.NET On April 19th, 2010 FDA launched he Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative. The Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format. The site includes new information such as basic information about medical devices and how FDA regulates those products, information about medical devices before and after the products are on the market, in a searchable database, information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices, memos from FDA employees explaining the reasons for the agency's decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device as well as a step-by-step guide for manufacturers of
1 comment
Read more

Risk Based Clinical Monitoring

BayBiotech.NET FDA's recommendation of Risk Based Monitoring of Clinical Trials , as published in their Draft Guidance in August 2011. For the first time, FDA provided guidance on monitoring of clinical investigations in 1988 which was recently withdrawn, stated that the “most effective way” to monitor an investigation was to “maintain personal contact between the monitor and the investigator throughout the clinical investigation.” At the time the guidance was issued, sponsors had only limited ways to effect meaningful communication with investigators other than through on-site visits.   This guidance recommends an assessment by the sponsor for the need of 100% on-site monitoring. Such an assessment may be based on the complexity of the study protocol and not be generally applicable to all trial types. It explains the importance of remote monitoring facilitated by the use of electronic data capture system (EDC) and also emphasizes the need of the identifying critical
1 comment
Read more