Chino.io, a cloud-based data security platform for digital health companies, has received ISO 13485 certification, a standard that defines that quality management systems (QMS) for manufacturers of medical devices.
The certification is a requirement for many markets to show that a company has a good standard quality management system in place – incorporation medical device directives, regulations and responsibilities.
The ISO 13485 certification builds on the ISO 9001 certification. Its differences include:
- Emphasis on risk management activities during product development;
- Focus on specific guidelines as a management responsibility. For example, the Quality System Regulation 21 CFR 820 (QSR) for medical devices sold in the United States;
- Work environment controls to ensure product safety;
- Requirements for documentation and validation of processes for sterile medical devices;
- List of effectiveness indicators for Corrective and Preventive Actions;
- Requirements for inspection and traceability for implantable devices.
Chino.io’s product is specifically aimed for medical data storage, claiming that certification reduces any compliance burden on its clients.
The company’s level of data security includes encryption, granular access control logs, immutable audit logs, right to be forgotten and all requirements defined by US and EU data protection laws for healthcare.