ISO 13485

GENERAL REQUIREMENTS

The ISO 13485 standard contains specific requirements for manufacture, installation and servicing of medical device, which strongly focus on the compliance of EU Directives for MD or IVD such as:

• Provision of technical documentation (medical device file / technical product file)
• Specific design & development requirements
• Implementation of a risk management process to product development and product realization.
• Validation of processes.
• Health, safety and staff hygiene requirements
• Change management, market observations and procedures for product recall
• Compliance with statutory and regulatory requirements
• Effective product traceability and recall systems.

Here are the documents needed for compliance with ISO 13485:2016

• Quality policy and Quality objectives.
• Medical Device Quality management system manual.
• Mandatory procedure for Medical device process management.
• Requirements for infrastructure and maintenance activities
• Requirements for work environment
• Arrangements for control of contaminated or potentially contaminated product
• Process for risk management in product realization
• Procedure and records for servicing of the medical device, service validation.
• Procedure and records for data analysis and corrective actions