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10 Things You need to know about Human Factors Validation

10 Things You need to know about Human Factors Validation

As medical devices become more complex, the FDA will continue to place greater emphasis on ways to improve safety and effectiveness before products are commercialized. One relatively recent method is Human Factors Engineering, also known as Usability Engineering, which is used to identify and mitigate use errors. Of course, this can place additional burdens on manufacturers to justify that their device has accounted for as many of these potential risks as possible. The list below, which is by no means exhaustive, is intended to point you in the right direction as you prepare for meeting FDA requirements for Human Factors Validation Testing. Human Factors should be considered throughout the design and development process, not just when you’re ready to go to market. Formative evaluations, such as focus groups and expert interviews, can and should be conducted throughout the design and development process. These studies usually consist of 5-8 people and can be conducted somewhat informally. Valuable information can be gleaned from formative evaluations, such as design improvements and identification of potential use errors that could be mitigated by making adjustments to the device interface. Additionally, the FDA and other notified bodies often want to see how your design has been influenced based on the results of these studies. Summative evaluations are the formal validation studies conducted for the final version of the device. These studies are your Human Factors Validation Testing that must follow the requirements of the FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices, and the EU standard, IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices. These studies...
Transitioning to ISO 13485:2016

Transitioning to ISO 13485:2016

In the event that you have not heard, ISO 13485 has undergone a major revision. As a quick recap, ISO 13485:2003 was overhauled by the technical committees in order to align more closely with regulatory requirements. The new version introduces a risk-based approach. This doesn’t mean that the traditional process approach has gone away, it means that risk management and risk analysis are going to play a greater role in how companies manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system. Read The New ISO 13485:2016 – Procrastination Can Cost You to learn more about the differences between the versions. What’s the Time Line for Transitioning to ISO 13485:2016? Ultimately, ISO 13485:2016 will replace ISO 13485:2003; however, over the course of the next three years (March 2016-2019), the standards will coexist. This will give manufacturers, notified bodies and regulators time to transition to the new standard. According to a transition planning guidance by ISO, organizations will be accredited for either edition for the first two years of the transition period. After the second year, new accreditation will only be given for ISO 13485:2016. After year three, any existing certification for ISO 13485:2003 will no longer be valid. In reality, this does not give you time to procrastinate. When you see the level of requirements you will have to account for, you will realize that taking necessary action should be a top concern. Preparing for the ISO 13485:2016 Transition Process Step 1: identify resources necessary to help implement the new standard Identify what will be needed (e.g. document review, gap...
The NEW ISO 13485:2016 – Procrastination Can Cost You

The NEW ISO 13485:2016 – Procrastination Can Cost You

ISO 13485 is the international standard medical device companies follow to demonstrate their ability to consistently meet both customer and regulatory requirements with their devices and related services. Regulators worldwide, including the EU, Canada, Australia and Japan, have integrated ISO 13485 into their regulatory requirements. The standard is designed to be used by organizations throughout the lifecycle of a medical device, from conception to production and post-production, including final decommission and disposal. It also covers storage, distribution, installation and servicing and the provision of associated services.1 This standard has created a common understanding between regulators and the industry as to what is required for a quality management system, although many countries will have their own regulatory requirements in addition to ISO. If you are marketing only in the US, compliance to ISO 13485 is not required; however, it does provide your company with a marketing advantage by showing your company’s commitment to quality, continual improvement and bringing safe and effective products to market. Coexisting Standards In March 2016, the third edition of ISO 13485 was released, which was the first major revision in 13 years. Because many countries had either revised or added regulations, ISO determined that an update was necessary to ensure quality management system requirements aligned with regulatory requirements. Ultimately, ISO 13485:2016 will replace ISO 13485:2003; however, over the course of the next three years, the standards will coexist. This will give manufacturers, notified bodies and regulators time to transition to the new standard. According to a transition planning guidance by ISO, organizations will be accredited for either edition for the first two years of the transition...