Compliance is necessary for manufacturers seeking approval in the EU, USA, Asia, Australia, and other major markets. As it will be classified under medical devices, it will be subject to the ISO 14971 standard which includes the following procedures;
·        Identifying hazards associated with the device
·        Estimating the potential probability of the risks occurring
·        Developing and implementing safeguards if any
·        Regular reviews and monitoring to assess the effectiveness of safeguards implemented.
 
Just like other ISO standards, certification Isn’t a necessity but is generally a good investment idea in the long run for many companies and startups
 
The process generally is crucial for many companies and as a result, they have pumped a lot of resources to ensure they are ISO compliant in general for the various structures it may fall under, and this is quite apparent for, medical devices. Various regulation bodies all over the world demand this process be done with machines that exhibit a high level of accuracy. All the components that make up the machine are to be of a high degree of reliability and that the materials used are appropriate for the application. To help in uniformity, the devices are almost always shipped to an ISO/IEC 17025 facility that is accredited for calibration and testing
 
Reasons for compliance
·        There are various reasons to have a product is compliant and it all boils down to good business practices.
·        To ensure the proposed item is safe to use
·        To allow for the ease of certification by organizations around the world
·        To verify the product is suitable for the market
·        To achieve product listings as required by the various regulatory bodies
 
The ISO compliance procedure isn’t a full-proof operation as human beings are involved throughout the whole process and thus may fail to be a full-proof process. Some of the problems that may arise due to human error. This may include: failure to calibrate equipment as per the requirements resulting in the wrong results, multiple cleric errors, loss of evidence among many others (Anon., 2021)