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ISO Standards Development
The International Standards Organization (ISO) is the primary international body responsible for development worldwide standards in quality, environmental, safety, regulatory environment. Within the ISO body, technical committees (TC's) are set-up to focus on specific areas where standards are to be developed. The Technical Committees are staffed by experts in their area, who come from i...
 
ISO Standards Development
Health care providers typically place endotracheal tubes into a patient's airway (trachea) to help establish and maintain their airway and to ensure the adequate exchange of oxygen and carbon dioxide. The Vyaire Medical Tri-Flo Subglottic Suction System can be used to remove liquids or semisolids that block an adult patient's airway when an endotracheal tube is in place.

Reason for re...
 
Two service management standards have been updated. namely ISO/IEC 20000-1:2018 and ISO/IEC 20000-10:2018. The former details "requirements for an organization to establish, implement, maintain and continually improve its service management system". The latter standard, details relevant concepts and terminology.

The standards are primarily of interest to those in the IT sector, howeve...
 
The CyPass Micro-Stent is used to treat open angle glaucoma during cataract surgery.  In 2016 the CyPass Micro-Stent was approved by the US FDA based on 2 year data. Due to the critical nature of the device (it is inserted into the eye), and the potential for longer term adverse effects, the FDA required longer term data collection as part of the device approval. Based on information f...
 
Apple Series 4 Watch is now a Medical Device. (September 2018)
"The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your De Novo request for classification of the ECG App, an over-the-counter device under 21 CFR Part 801 Subpart C, with the following indications for use: The ECG app is a software-only mobile medical...
 
Why validate a medical device
Validation is gathering and analyzing data to confirm that a product or process will consistently perform as expected. Process validation is performed to confirm that a process will consistently operate as designed. Product validation will confirm that the product can repeatedly perform as designed. When products and processes are effectively validated, there will be a high level of conf...
 
Why validate a medical device

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