From medical equipment to MRI machines and wound dressings, they all help save lives and improve the quality of daily life. There are currently about 500,000 different technologies, and the number of medical devices continues to grow as the population grows, advances in medicine, and the prevalence of chronic diseases increase. The value of the global medical equipment industry is estimated to reach a whopping $ 612 billion by 2025.
ISO has many international standards and guidance documents that help keep your products safe and effective while meeting many of the national, regional and international regulatory requirements that must be met. Recently, the latest additions have been published with the aim of helping manufacturers by providing tips on correct product information and effective monitoring of the device after entering the market.
ISO 20417, Medical Devices – The information provided by the manufacturer facilitates the process of regulating product information by providing general requirements that are compatible on all devices and in all geographical locations. The new standard will serve as the main source; Therefore reduces the likelihood of recurrence.
ISO / TR 20416 Technical Report, Medical Devices – Monitoring for manufacturers provides guidance on effective monitoring of the safety, performance and usability of the device in everyday use. This is essential to be able to quickly identify adverse effects while also highlighting areas for improved safety, performance and usability.
The two goals are to help manufacturers improve their products and comply with all rules and regulations in an integrated manner, said Will Vargas , director of the ISO Technical Committee, which developed the standards.
“Through consultation with industry experts from around the world, as well as with many regulations and other standards and guidelines in this area, we have done a lot for manufacturers,” he said.
Thus, these two documents include not only the best international practice; Rather, it assists manufacturers in complying with national and regional regulations and recommendations such as those relating to the International Medical Equipment Regulatory Association, EU guidelines on medical devices and many other international standards, including ISO 13485, medical devices, management systems. Quality – Comply with legal requirements.
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