Best Practice in Product and Process Improvement. Current and Emerging Regulations & Standards. Etc. …

Information and Training. | Total Quality Management.
A Brainstorm Process can be a highly effective method for identifying causes of problems or for extracting approaches to solving problems, however, it can at times be over-shadowed by other improvement methods. The Brainstorming process when effectively implemented will generate a broad range of positive and creative ideas from the p...
 
Information | Understanding | current Best Practice.

 
When to Validate. When to Verify. Validation vs Verification.
Validation vs Verification: Where the results of a process cannot be fully verified by subsequent inspection and test, and that process influences critical attributes of a product or process, then the process should be validated with a high degree of assurance an...
 
Medical Device Apps and FDA Requirements
Information & Training. | Medical Devices.
“FDA will focus on Apps with higher levels of patient and user risk and apply discretion to Apps with lower risk potential”. The Medical Device FDA Requirement outlines a medical device as a product that is intended for use in the diagnosis, treatment, or prevention of a disease or other human health condition. Clearly for the FDA to tr...
 
Medical Device Apps and FDA Requirements
Waterfall Model
Software Validation.
The waterfall model approach to software Development and Validation, could be considered the original software life cycle model. In this model, the development of software, initiates with the concept stage and progresses through to the final product. As the software development process is implemented, the software is continually transformed until the final product i...
 
Waterfall Model
Overall Equipment Effectiveness
Information | Understanding | Best Practice.
Measurement of OEE (Overall Equipment Effectiveness) is based on understanding the “Availability”, “Performance” and “Quality” of an item of process equipment (or other asset under review) and the “Planned Production Time”.

 
“Planned Production Time”.
The “Planned Production Time” is “all time” less the ...
 
Overall Equipment Effectiveness
Classification of Medical Devices per European Medical Device Directives.
Information & Training. | Medical Devices.
The classification of medical devices in Europe is governed by Annex IX of the Medical Devices Directive 93/42/EEC.

The first stage in any classification process is to ensure that your product is indeed a medical device and comes under the rules of the relevant European Directive. To be classed as a medical device, the medical device nee...
 
Classification of Medical Devices per European Medical Device Directives.

MedicalDeviceValidation-small_03
Information & Training presentations. … …