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AFAP As Far As Possible. Risk reduction requirements for Medical Devices.
“As Far As Possible” (AFAP) versus “As Low as Reasonably Practicable” (ALARP).

Risk Management in Medical Devices.

 

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 ...
 
AFAP As Far As Possible. Risk reduction requirements for Medical Devices.
ISO 14971 2019 Risk Management in 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 devices. Risks can be related to injury, not only t...
 
ISO 14971 2019 Risk Management in Medical Devices.
ISO 31000 2018
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 greater emphasis on the involvement of senior man...
 
ISO 31000 2018
Integrated Risk Management
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...
 
Integrated Risk Management
Software Validation Training
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 involve a group meeting to assess a work product. Software tech...
 
Software Validation Training
Team Communication
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 ...
 
Team Communication

MedicalDeviceValidation-small_03
FDA GMP’s, EU MDR’s, Process Validation, Risk Management, …… …