Quality and Compliance
Certified quality, searchable documents.
ASMED® quality management system is ISO 13485:2016 certified. Public device certification and registration documents can be found on this page.
The quality system
ASMED® designs, manufactures and assists medical devices with a quality management system certified according to the international standard ISO 13485:2016, specific reference for medical device manufacturers.
Compliance covers the entire life cycle of the device: design, production, traceability, post-market surveillance and technical assistance.
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Design and production in compliance with international standards
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Traceability at every stage of the device life cycle
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Comprehensive and up-to-date clinical and technical documentation
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Post-market surveillance and ongoing assistance
Certification issued by an independent body. The certificate can be downloaded below.
Public documents
Certifications and registrations
IMQ certificate — ISO 13485:2016
Quality management system of ASMED S.r.l. IMQ certificate no. 9124.ASM5.
Download the PDF →ANVISA register – BENE Mod 110
Registration of the device BENE Mod 110 with the Brazilian regulatory agency, in the name of ASMED Latino América. Notification 25351369484202435.
Download the PDF →INMETRO Certification - BENE Mod 110
Certification QC-2701-23 of the device BENE Mod 110 for the Brazilian market, requesting ASMED Latino América.
Download the PDF →EC declaration of conformity
Manufacturer’s declaration, EC certificate ECM19MDD009 and Notified Body confirmation for the device BENE Mod 110: extended to 31 December 2028.
Download the PDF →Documents are published in the most recent version available. For verifications or requests for additional documentation, contact ASMED®.
Regulatory compliance
ASMED® devices are placed on the market in accordance with the European regulatory framework for medical devices. The information on this site is intended for professional operators (Legislative Decree 46/1997, art. 21) and does not replace the technical documentation: indications, contraindications and warnings are those given in the instructions for use of each device.
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