Quality management systems for medical devices and in vitro diagnostics
The international standard ISO 13485 forms the basis for the certification of quality management systems in companies that manufacture or distribute medical devices - or that are involved in their manufacture as part of the supply chain.
Quality management systems for medical devices and in vitro diagnostics (SCC)
A quality management system forms the backbone for the activities and tasks of a medical device manufacturer. It ensures that internal and external regulations to be complied with are reliably taken into account and adhered to.
Appropriate certification enables a manufacturer to build confidence in its processes and products and demonstrate its commitment to safety and quality.
What is ISO 13485?
ISO 13485 is a stand-alone standard for quality management systems for manufacturers of medical devices or in vitro diagnostics, derived from the internationally recognized and accepted EN ISO 9000 series of standards. ISO 13485 continues the process-oriented approach of ISO 9001 and supplements it with specific aspects that are of particular importance for manufacturers of medical devices or in vitro diagnostic medical devices.
What are the contents of ISO 13485?
ISO 13485 supports manufacturers in developing a quality management system that enables safe and effective processes. These processes are designed to ensure the consistent design, development, production, installation, delivery, monitoring, tracking and disposal of medical devices, covering their entire product life cycle.
This is to ensure that medical devices and in vitro diagnostic medical devices can be used safely for their intended purpose.
What is the legal significance of ISO 13485?
Regulatory approval programs for medical devices or in vitro diagnostic medical devices are often based on requirements of ISO 13485. The general requirements of ISO 13485 are expanded and adapted to specific legal market requirements through concretizations and supplements.
Process reliability through documented procedures
Proof of compliance with legal requirements
Increased product safety for patients & users
Increased customer & employee satisfaction
Highlighting the competence of the company
What is the difference between ISO 13485 and EN ISO 13485?
While ISO 13485 is the internationally recognized basic version of the standard, it has been harmonized into a European standard by the European standardization body for its consideration in European regulatory approval procedures.