ISO 14971: 2012 and IEC 62304: 2006 mitigate risks in medical device software

ISO 14971:2012 and IEC 62304:2006 are related but different global standards for risk management pertaining to software used in medical devices. Judicious application of these two standards is the way to go for medical device companies.

ISO 14971 and IEC 62304:2006 are global standards that govern risk management and lay out regulations and guidelines for software used in medical devices. The need for regulation of software in medical devices arises from the fact that software is the heart of a medical device. It is the medical device’s software that ensures that the device performs its intended purposes. Hence regulation is of utmost importance to enable medical device and software organizations facilitate this in their products.

The ISO 14971: 2012 -a brief understanding

  • The primary aim of ISO 14971, the global regulatory compliance standard is to ensure that a medical device carries medical safety into it
  • This standard requires medical device manufacturers to undertake steps and measures by which they can foresee and eliminate risks in a medical device in the optimal manner
  • Taking off from the above point, ISO 14971 requires medical devices to take steps to at least mitigate risks to the best extent. The ISO 14971standard prescribes the processes necessary for enabling this.

The ISO 14971’s update in 2012

In 2012, the ISO carried out an update to the application of this standard within the European regulatory framework. This amendment to ISO 14971: 2012 is at the periphery and not at the core. Annex ZA is the main area in which this standard has been updated:

The use of the “As Low as Reasonably Practicable” (ALARP) approach is from now excluded in the risk acceptance process. This standard proscribes labelling as a risk control measure that can play a role in decreasing risk occurrence.

The IEC 62304:2006

The requirements for medical device software’s life cycle are stated in IEC 62304:2006. This standard’s group of activities, processes and tasks creates a common basis for the software life cycle processes in a medical device.

When it comes to the risk management aspect, IEC 62304:2006 supplements and strengthens ISO 14971. If ISO 14971 is the global standard for the development of medical software; IEC 62304:2006 standard is concerned with medical device software and their software lifecycle processes.

The following tripod of software-related issues forms the IEC 62304:2006’s foundation:

These three attributes form the backbone of the test of a medical device company’s successful compliance with the regulatory requirements. For a medical device company to be successful in applying ISO 14971:2012 and IEC 62304:2006; it has to implement a cross-standard and resourceful way of integrating activities covering these requirements documents.

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Six Systems Approach to Pharmaceutical cGMP Regulations

Six Systems Approach to Pharmaceutical cGMP Regulations.

The FDA has enacted several pharmaceutical cGMP regulations. These are key concepts that are critical to quality systems. Some of the concepts by which the FDA and other regulatory bodies ensure cGMP regulations are Quality, Quality by Design (QbD) and product development, Quality Risk Management, Corrective and Preventive Action (CAPA), Change Control, and the Six Systems Approach.

Of these, the six-system inspection approach is a systems-based approach to cGMP and is aimed at ensuring a robust quality system model for pharmaceutical products.

It consists of the following:

Quality System

• Facilities System
• Equipment System
• Materials System
• Production System
• Packaging & Labeling System

Quality system is the fulcrum

It needs to be borne in mind that the whole system centers round the organization’s quality system. The quality system is the pivot around which the systems approach revolves. It is the core and the very foundation for the manufacturing systems that are linked and function within it. 

The FDA does not consider the quality system as different or separate from the five elements. In this sense, it the quality system model may be considered the root from which the five elements branch out.

In other words, the five manufacturing systems integrate themselves them into the respective and appropriate sections of the model. The order of interplay and interdependence may vary slightly from one organization to another, but to those in the knowhow of the six-system inspection approach; the rationale by which the inter-relationship plays out is quite readily apparent.

State of control –the crux of the matter

The entire purpose of having a systems approach in which the systems are independent, yet integrate into each other seamlessly is that having a systems-based inspection compliance program ensures that the organization is equipped with the ability to assess whether each of the systems is in a state of control.

 References:

http://www.fda.gov/downloads/Drugs/…/Guidances/UCM070337.pdf

Thanks & Best Regards,
John Robinson
GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
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Email: john.robinson@globalcompliancepanel.com