Quality & Certifications
Quality Management
Shanghai Ascend Medtech operates under a quality management framework aligned with ISO 13485 (Medical Device Quality Management Systems). All supplied products are sourced from manufacturers with documented quality systems.
Certifications (Product & Manufacturer Dependent)
Certification status varies by product model, configuration, legal manufacturer, and destination market. The following certifications are available across our product portfolio:
- ISO 13485 — Medical Device Quality Management Systems (manufacturer-level)
- ISO 9001 — Quality Management Systems (manufacturer-level)
- CE Marking — European Conformity (product-level, model-dependent)
- FDA — Selected products (model and configuration dependent)
Certification Policy
We do not make blanket certification claims. Each product-model-destination combination is verified individually. Certification documents are provided upon quotation request for specific models and destination markets.
Documentation Available Per Product
- Datasheets & technical specifications
- User and service manuals
- Packing information
- Applicable quality and conformity documents (by destination market)
- IEC 60601 electrical safety reports (for applicable devices)