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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
Mind Mapping.
Brainstorming.
The “Round Robin” approach.

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 on these ideas. One of the problems inherent with the “free form” approac...
 
Mind Mapping.
Tools & Techniques in Medical Device Risk Management.
Listed below are links to a cross-section of documents related to:

Medical Device Validation, Regulation, Compliance.
Quality Assurance, Quality Management Systems.
Product and Process Validation.
Risk Management and Risk Control.
Statistical Process Control and Process Capability Analysis.
Lean Manufacturing, Just in Time Processing.
Total Quality Management.
Software Validati...
 
Tools & Techniques in Medical Device Risk Management.
Risk Management information & training presentation.
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 intent is achieved.  Risk must be managed when ...
 
Risk Management information & training presentation.
FDA GMP QSR: Equipment and Maintenance.
Consider the following analogy between electronic signature control versus a documentation based method of control, "writing a cheque versus making an ATM withdrawal". 

The documentation based method of control: The cheque details indicate an instruction to be followed by the bank. The cheque book contains the account details. The act of writing the cheque is an SOP (standard oper...
 
FDA GMP QSR: Equipment and Maintenance.
Tools & Techniques in Medical Device Risk Management.
Total Quality Management aims to optimize the performance of an organization via continual improvement in the products and services provided, the operation of the internal and external processes, equipment, utilities and most of all the people involved in an organization.
The net result is a relentless positive improvement in all aspects of an organization’s performance, for example, ...
 
Tools & Techniques in Medical Device Risk Management.

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