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

How Standards are Developed
Information & Training. | Quality Assurance. Quality Management.
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 Tech...
 
How Standards are Developed
Medical Device Recall
Information & Training. | Medical Devices
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 ...
 
Medical Device Recall
Why validate a medical device
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 hig...
 
Why validate a medical device
Process Improvement Constraints
Information & Training. | Total Quality Management.
Round Robin Brainstorming.
The “Round Robin” Method.
Round Robin Brainstorming is a widely applied and very successful method directed towards problem solving and continuous improvement. In the traditional “free form” brainstorming session, team members are encouraged to suggest ideas, and other team members try to build ...
 
Process Improvement Constraints
Risk Management Process Training
Information & Training. | Risk Management.
Effective risk management is critical in the operation of all businesses. Risk management needs to be applied when seeking to ensure employee, customer and all stakeholder safety, when a business is aiming to optimize product & process quality and reliability. Risk assessment and management is a key component in determining that design ...
 
Risk Management Process Training
FDA Part 11 Electronic Records Electronic Signatures
Information & Training. | Medical Device Validation, Regulation, ...
The US Food and Drug Administration (FDA) issued a regulation that provided criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. With this regulation, titled Rule 21 CFR Part 11, electronic records can be equivalent to paper records and handwritten signatures.
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FDA Part 11 Electronic Records Electronic Signatures

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