The international standard DIN EN ISO 14971 governs risk management processes, which is a legal requirement in compliance with ISO 13485 and in many countries around the world for the development and production/ distribution approval for medical products.

Rhein S.Q.M. service description:

Competent Rhein S.Q.M. support for risk analyses and assessments, and for the development of measures to eliminate and/or control recognised risks - we can offer a comprehensive service for the entire supply chain where required. A practise-oriented and useful documentation will be provided as a matter of course. We will also be happy to consult during your practical implementation phase of the required measures.

Benefits for our clients:

You will fulfil the most stringent requirements for risk management regarding medical products, and will receive practical and top-quality documentation, which can be used as the basis for any approval needs that may arise during the course of the certification process.