Independent conformity assessment and notified body services for medical devices and IVDs under EU regulations. Provides technical documentation review, quality management system audits, and certification support to facilitate market access compliance.
Manufactured by
Szutest
Frankfurt am Main, Germany
SZUTEST Konformitätsbewertungsstelle GmbH is a notified body appointed by the German Competent Authority under the Medical Devices Regulation (EU) 2017/745. SZUTEST Group Companies, with over 15 years of experience, collaborates with global manufacturers to provide reliable and comprehensive certification services. Through our advanced software infrastructure, we are committed to delivering fast, reliable, and effective solutions to our partners. In the field of medical devices, we are accredited to ASTM standards under EN ISO/IEC 17025 for the static and fatigue testing of implants and prostheses, as well as for the tensile and peel testing of sterilization pouches. To provide higher quality services globally, we have authorized offices in strategically important locations such as Germany, Malta, Turkey, and South Korea. #Medica2024 #HealthcareTechnology #Excellence in medical device testing and certification.
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Notified Body certification services for medical devices seeking EU regulatory approval. Provides compliance assessment, technical documentation review, and quality management system evaluation to support CE marking and market authorization across device classifications.
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