Best Practice in Product and Process Improvement. Current and Emerging Regulations & Standards. Etc. …
“As Far As Possible” (AFAP) versus “As Low as Reasonably Practicable” (ALARP).
For manufacturers of medical devices, when looking to manage and reduce risk, many have looked to the ISO 14971 standard as a means of managing the risks associated with the manufacture and processing of their medical device. This standard references and suggests the use of ALARP. As a result ALARP ...
For manufacturers of medical devices, when looking to manage and reduce risk, many have looked to the ISO 14971 standard as a means of managing the risks associated with the manufacture and processing of their medical device. This standard references and suggests the use of ALARP. As a result ALARP ...
Information & Training. | Medical Devices
The ISO 14971 standard has been developed for those involved in the manufacture of medical devices, however it can be used as guidance in developing and maintaining a risk management process for other products that are not necessarily medical devices.
The standard deals with processes for managing risks associated with medical device...
The ISO 14971 standard has been developed for those involved in the manufacture of medical devices, however it can be used as guidance in developing and maintaining a risk management process for other products that are not necessarily medical devices.
The standard deals with processes for managing risks associated with medical device...
Information & Training. | Risk Management.
The ISO 31000, Risk Management Standard was first released in 2009. The standard is not specific to any particular industry or risk setting, but is designed to provide “best practice” guidance in all scenarios where risks can arise. The standard has been subsequently revised to the ISO 31000:2018 standard. This new revision provides a g...
The ISO 31000, Risk Management Standard was first released in 2009. The standard is not specific to any particular industry or risk setting, but is designed to provide “best practice” guidance in all scenarios where risks can arise. The standard has been subsequently revised to the ISO 31000:2018 standard. This new revision provides a g...
Integrated Risk Management (IRM) entails combining cyber security-based compliance, digital and cyber risk management, and corporate governance into a universal and streamlined approach. This gives businesses the benefit of enterprise-wide visibility into their cyber posture, besides enabling the meaningful automation of their risk management strategies.
In the current digital era, bu...
In the current digital era, bu...
Information & Understanding. | Software Validation.
Activities associated with validating software occur throughout the evolution of the product. There are numerous techniques and tools that may be used in isolation or in combination with each other.
Software Technical Review.
Includes techniques such as audits, walk-throughs, inspections. Most of these approaches involv...
Activities associated with validating software occur throughout the evolution of the product. There are numerous techniques and tools that may be used in isolation or in combination with each other.
Software Technical Review.
Includes techniques such as audits, walk-throughs, inspections. Most of these approaches involv...
Six Sigma Tools for Process Improvement are significant elements that are essential for your business process improvement. These tools help in identifying the flaws and weaknesses and eliminating them for an error-free result.
If you use the process systematically, it will help in increasing your employees' productivity and drive profits.
In this post, we will talk about the seven ...
If you use the process systematically, it will help in increasing your employees' productivity and drive profits.
In this post, we will talk about the seven ...
Information & Training presentations. … …