The power of predictability
In challenging and unpredictable circumstances, the world relies on as much predictability as it can. Being able to rely on safe, standardized, and predictable devices that can be deployed quickly shortens reaction time and allows for swift solutions.
If a device, like disinfectant solution for example, has consistently met the regulations necessary, this could potentially reduce the time taken to address problems that arise in the testing phase.
The Standard ISO 13485 specifies requirements for a quality management system within the medical device industry. It supports manufacturers within the industry to design quality management systems to establish and then continue to maintain the effectiveness and safety of their processes and products. Using a Standard like ISO 13485 increases a device's predictability, making it a valuable and safe contribution to the public's health, especially in challenging times.
Medical Device production in challenging times
Due to strict Standards and regulations, medical devices are usually seen to be dependable and predictable. Devices are rarely released on the market without being proven as such. Keeping devices safe, reliable, and predictable when producing in a crisis is just as important. If a manufacturer has implemented a risk management strategy that is 'always-on', then staying compliant despite external pressures is more easily achieved.
Constant compliance leads to predictability
ISO 14971 is a Standard that helps manufacturers within the medical device industry execute a risk management system at every stage. From design to production, this Standard helps manufacturers manage and lower the residual risk in their products at every point. The measures put in place are flexible and are able to remain in place regardless of challenging and changing circumstances.
For example, with sky-rocketing demand for PPE (personal protective equipment) manufacturers are working to produce more devices than normal. This added pressure on the system could result in managers or manufacturers cutting corners and decreasing the quality of the product. The ISO 14971 Standard can help to ensure manufacturers remain compliant despite pressures and time restrictions.
Manufacturers in the medical device industry producing reliable and predictable devices in challenging times, such as the COVID-19 pandemic, means lowering the risk of the public's health.
Compliant now, compliant always
With urgent demands and a growing divide between the supply and the demand for safe and reliable medical devices, those in the medical devices industry are urged to refer to their Standards and meet their regulatory obligations to work towards keeping the public safe.