ISO 13485 certification for medical devices
As an accredited certification body with global operations, TUV USA is a benchmark in ISO 13485 certification, focused on Quality Management Systems for medical devices.
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As an accredited certification body with global operations, TUV USA is a benchmark in ISO 13485 certification, focused on Quality Management Systems for medical devices.
Request your proposal now!Nowadays, fulfilment of clearly defined quality standards in business – and particularly in international business – is becoming ever more important. Part of this is the ability to adapt to changing markets and customer requirements and constantly develop new learning and improvement processes.
EN ISO 13485, as a quality management system for medical devices, describes requirements for regulatory purposes and describes the development, implementation and maintenance of a quality management system for medical device manufacturers and suppliers.
The standard contains detailed requirements for a quality management system which fulfils both customer requirements and the requirements for all life cycle stages of a medical device, including its components and the original raw materials used in manufacture, along with any related services.
A QM system according to EN ISO 13485 provides the ideal basis for modern organisations of every size to demonstrate competence and efficiency at home and abroad. Internal work processes, responsibilities and authorities are taken fully into account, as is the regulation of processes for interaction with customers and business partners.
EN ISO 13485 is similar in scope and intention to ISO 9001, but it contains additional requirements for medical devices and excludes certain provisions of ISO 9001. For this reason, in most countries certification to ISO 9001 is not an acceptable substitute for certification to EN ISO 13485.
Based on a functioning management system, individual company structures can be precisely tailored to the specific needs and specifications of the individual customer. Operational procedures can be designed so as to be flexible, and everybody benefits.
The manufacturer places Class I products on the market on his own responsibility. For products of Classes Im, Is, Ir, IIa, IIb and III, a conformity assessment procedure with the involvement of a Notified Body is needed. TÜV NORD CERT is a Notified Body as per Regulation (EU) 2017/745 on medical devices.
A QM system according to EN ISO 13485 provides the ideal basis for modern organizations of every size to demonstrate competence and efficiency at home and abroad. Internal work processes, responsibilities and authorities are taken fully into account, as is the regulation of processes for interaction with customers and business partners.
TUV USA combines technical expertise, regulatory knowledge, and global certification capabilities to help organizations navigate complex requirements with confidence.
Our advantages include:
Through the TÜV NORD GROUP, we support organizations in building compliant, market-ready medical devices aligned with international regulatory expectations.
Contact our experts today to discuss your certification needs.