Glossary Term
The process by which a person demonstrates specific knowledge, skills, or abilities in the view of a certifying body. Similarly, the process by which a product or process can achieve certification indicating its suitability for a specific purpose.
Performance Metrics
Company
certifications indicate our commitment to manufacturing and selling high quality products, as well as our commitment to continually improving our company, our products and our
Manufacturer
Glossary Term
The international quality-management standard for medical device manufacturing. Certification does not certify individual products, but suppliers with ISO 13485-registered production generally support tender documentation more reliably.
Regulatory Definitions
Partner
Siemens Healthineers runs an open sales-partner application with an online assessment form and a two-level certification model.
Glossary Term
An organisation designated by an EU member state to assess the conformity of products — including in vitro diagnostics — against applicable regulations before CE marking can be affixed.
Regulatory Definitions