Certifications and Quality Management
ISO 13485 Certification
Viamed Ltd. maintains ISO 13485 certification for quality management systems specific to medical devices, ensuring consistent quality and regulatory compliance.
Quality Management Systems
Comprehensive QMS covering design, development, production, installation, and servicing of medical devices.
Supplier Partnerships
We work only with certified suppliers who meet stringent quality and regulatory requirements.
Regulatory Support for EU Customers
MDR
Understanding of the Medical Device Regulation (EU) 2017/745 requirements and timelines for compliance.
CE Compliance Support
Assistance with CE marking processes and documentation for medical devices sold in the European Economic Area.
Import/Export Support
Guidance on customs procedures, documentation requirements, and regulatory considerations for moving medical devices across EU borders.
Documentation Availability
Instructions For Use (IFUs)
Comprehensive user manuals and operating instructions available for all products in multiple European languages.
Declarations of Conformity
Official documentation confirming product compliance with relevant EU directives and regulations.
Product Documentation
Technical specifications, data sheets, and application notes available upon request.
Note: All regulatory documentation is available upon request through our contact page. We maintain copies of essential documentation to support our EU distributors and customers' compliance needs.
EU Authorised Representative
Viamed Germany acts as the EU Authorised Representative for:
Teledyne Analytical Instruments
(a business unit of Teledyne Instruments, Inc.)
16830 Chestnut Street
City of Industry, CA 91748
U.S.A.
UK Responsible Person
Viamed Ltd. acts as the UK Responsible Person for:
- Sensatronic GmbH (Germany)
- ewimed Switzerland AG
- Teledyne Analytical Instruments (USA)
- Orantech Inc. (China)
- Ontecklong Medical Supply Corporation (China)