ISO 13485:2003
ISO13485 processes have been built into every stage of our manufacturing and quality assurance functions. We have specialized processes to ensure clean environmental conditions, risk management and traceability—some of the key elements of this standard.

CE0482
CE (a mandatory mark for placing a product in European economic Area) is typically done before any significant manufacturing takes place. Our products undergo rigorous testing procedures to comply with the standards associated with CE and prove effective in real life situations.

tandards
Our processes also remain up-to-date to meet the most stringent global standards.

IEC 60601
We conform to the IEC 60601-1 family of standards, the cornerstone document addressing many of the risks associated with electrical medical equipment.

EU & Medical Devices Directive
The MDD and EU directives cover the regulatory requirements of the European Union for Medical Devices to ensure medical products comply with a set of essential requirements relating to performance, health and safety.
Electromagnetic Compatibility (EMC) Directive: EU directive 2004/108/CE
Low Voltage Electrical Equipment Directive: EU directive 73/23/EEC
MDD 93/42/EEC