Safety requirements for medical devices

Safety requirements for medical devices

Safety requirements for medical devices have been shaped throughout the history of medical devices, gradually becoming more complex and complemented by new items. Medical device manufacturing is a fast-growing industry that offers increasingly sophisticated and innovative solutions based on unique technologies. As devices and equipment become more technologically sophisticated, the evaluation criteria that clinics and…

Australian Register Therapeutic Goods for Medical Devices

Australian Register Therapeutic Goods for Medical Devices

Therapeutic commodities are health-related items. Medical implants may be utilized to treat or prevent disease, change the body’s fluid balance, avoid or detect pregnancies, and replace or remodel parts and structures of the body. Healthcare equipment like stitches and band-aids are examples of therapeutic goods. Additional examples include antiseptics and blood products and supplementary and…

ISO 13485 Medical Devices

ISO 13485 Medical Devices

Safety in quality is very important in the medical devices space. Regulatory requirements are becoming increasingly stringent throughout the product lifecycle, with a focus being placed on competence, requirements, and design validation activities. In addition, there is a larger expectation for organizations to not only demonstrate product compliance, but adherence to their own quality management…

IVDR IVDD Changes

Proposed changes to IVDR transitional arrangements.

The Covid pandemic has seen some significant disruption in the release and adaptation of new (and revised) regulatory requirements globally. None mores so than the release of MDR and IVDR. We thought we would share some proposed amendments to the IVDR (Regulation EU 2017/746) around transitional arrangements moving from IVDD (Directive 98/79/EC). The intent is…

Importing from China – Some real considerations

The current economy makes turning to China for goods worthwhile. Even with manufacturing and custom parts, China organisations are more than willing to accept low MOQ’s to increase trade. All these things make it appealing for smaller businesses (and large ones alike) to turn to our Chinese friends for services and goods. However, there are…

Make use of Usability. How to get it right… and wrong.

In the medical device world, Usability Engineering (IEC62366 The application of Usability Engineering or its 60601 counterpart IEC60601-1-6) is a required tool within the validation of a medical device. Regardless of if it’s, software, active, or IDV, Usability engineering helps us understand how the device (or system) react within a real-world application. It draws from the…