what is the difference between iso 13485 and 21 cfr 820?

For example, the Quality System Regulation 21 CFR 820 (QSR) for medical devices sold in the United States

Focus on specific guidelines as a management responsibility.

Emphasis on risk management activities during product development.

Main differences between ISO 13485 and ISO 9001: So in order to reach that gap, you need to do extra work and and provide your own liability to prove that your technologies meet the quality requirements for medical context. However, the ISO 13485 contains additional, specific requirements for medical devices and reformulates some of the requirements of ISO 9001. The ISO 9001 is similar in scope and purpose to the ISO 13485 standard and it defines procedures on how to implement a QMS. MDR and eHealth: How to build MDR compliant applicationsĭownload here But, my cloud provider is ISO 9001 certified. In addition to the ISO 13485, Chino.io is also ISO 9001 and ISO 27001 certified, which helps us to cover all quality and security aspects not found in ISO 13485 that are good for all businesses. This means that you can use our secure Database as a Service and API to ensure GDPR and HIPAA compliance, cut time to market, costs, and eliminate risks related to health sensitive data management. Therefore, Chino.io certification saves your time and money providing you all necessary guarantees that are required for building your medical grade applications. So if your suppliers are not ISO 13485 certified, then you must put in place necessary procedures, tests, monitoring activities, and documentation to demonstrate their compliance, before going to the market. This means that you are responsible for ensuring that all your components and their suppliers have an adequate level of quality for being part of your product. To develop your applications or connected devices you are going to use different cloud technologies, libraries and tools.

So, the latter will be suspended in May 2020, but in any way it’s only the Medical Device Regulation 2017/745 that counts from then on. Nevertheless, a transition phase of three years (medical devices) or four years (in-vitro diagnostics) was granted that allows companies to certify according to the old directive, the Medical Device Directive.

If you are developing a medical grade application or connected device, the ISO 13485 provides you the de facto mechanism to demonstrate compliance to regulations such as the new EU Medical Device Regulation (MDR),that came into force in May 2017. In a nutshell, why is Chino.io ISO 13485 important to you? This makes us the only Database as a Service (DBaaS) and platform who has necessary certifications to support your development of connected medical devices and health applications. We at Chino.io are proud to announce that we are ISO 13485:2016 certified.

What is the difference between iso 13485 and 21 cfr 820?