Quality commitment
ONAVITAL Certifications:
- A PORTABLE and TRANSIT OPERABLE medical device as per IEC 60601-1-11:
- No skin sensitization according to ISO 10993-10:2021.
- Radioelectric disturbance emission compliance according to EN 60601-1-2:2015+A1:2021.
- Immunity tests to electrostatic discharges according to EN 61000 – 4 – 2.
- Immunity tests to electromagnetic fields according to EN 61000 – 4 – 3.
- IP65 degree of protection provided by enclosures according to EN 60529:201.
- Degree of protection against shock according to EN 60068-2-27:2008.
- Degree of protection against drops according to IEC 60601-1-11:2015.
- Degree of protection against vibration according to EN 60068-2-64:2008
ISO 13485: is an internationally recognized quality management system (QMS) standard specifically designed for the medical device industry. It outlines the requirements for a comprehensive system to ensure the design, development, production, installation, and servicing of medical devices consistently meet customer and regulatory requirements.
AEMPS Medical Device Manufacturer License: The manufacturing license granted by the Spanish Agency of Medicines and Medical Devices (AEMPS) is an essential requirement for any company wishing to manufacture medicines or medical devices in Spain. This license ensures that the manufacturer complies with the necessary regulations and standards to guarantee the quality, safety, and efficacy of the products.
