ISO STANDARDS: IMPLEMENTATION AND MANAGEMENT FOR MEDICAL DEVICES

ISO 27001 – Information Security Management
Implementation: Establishing an ISMS certified to ISO 27001 and additional 27000 family standards, managing information security risks to ensure data confidentiality, integrity, and availability.
Management: Regularly updating the ISMS to address evolving security threats and maintain compliance with the latest information security practices.

ISO 13485 – Medical Devices Quality Management Systems
Implementation: Developing a QMS that complies with ISO 13485, focusing on consistent and safe medical device design, development, production, and post-marketing.
Management: Continual monitoring and improvement of the QMS, including regular internal audits and management reviews.

ISO 14971 – Medical Device Risk Management
Implementation: Establishing a framework for risk management throughout the medical device lifecycle, in line with ISO 14971, to ensure identification, evaluation, and control of risks associated with medical devices.
Management: Ongoing assessment and management of risks, adapting to changes in technology and regulatory requirements, and ensuring continuous risk control.