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

Validation requirements for Medical Device products.
Information & Training. | Medical Devices.
The Therapeutic Goods Administration (TGA)
is responsible for developing and enforcing the Australian Medical Device Regulations.
 

The Australian regulatory guidelines for medical devices (ARGMD) describes the information to be supplied with applications to import, export, manufacture or supply medical devices in Australia. The A...
 
Validation requirements for Medical Device products.
Benchmarking
Information and Training. | Total Quality Management.
The objectives of implementing a benchmarking program, for an organization are many and varied, however usually include some or all of the following reasons....

To determine who is the best out there in terms of a specific or range of capabilities. To identify world-class performance levels. To determine the drivers of superior pe...
 
Benchmarking
The 5S Method
Information | Understanding | Best Practice.
 
How the 5S method of control is implemented.
The "5" relates to a "5" level standard for organization of the workplace. The 5 levels progress from most disorganized to most organized as follows:

– 1S = ‘Seiri’ = Sort = Cleaning up: eliminating non needed material.
– 2S = ‘Seiton’ = Storage = Organizing: creating a pla...
 
The 5S Method
visual management
Information & Training. | Lean Manufacturing. Just In Time Processing.
 
Visual Management. A key driver of Process Improvement.
Visual Management is a system that enables an individual to immediately recognize the expected standard of performance and any deviation from it. Visual management develops and promotes an organizational culture where individuals and teams are encou...
 
visual management
Risk Management Training
Information & Training. | Risk Management.
Risk management can be defined as .... "the systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risk". Risk management training needs to provide an understanding of why an organization needs to implement a risk management process, how to approach in terms ...
 
Risk Management Training
Product Improvement
Information & Training. | Product Improvement.
Employees at all levels in organizations are expected to focus on contributing to identifying opportunities for product improvement and where possible driving such improvements within their respective areas of responsibility. How do they go about? The answer will clearly depend on the job scope of the employee. An engineer may be respon...
 
Product Improvement

MedicalDeviceValidation-small_03
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