Rekovar Receives BSI Certification for ISO 13485 Quality Management for Medical Devices

Rekovar, Inc. is proud to announce that we have been certified by BSI for ISO 13485: Quality Management Systems for Medical Devices for the design development, and production of our NeoMonki Neonatal Monitoring Kit. This certification highlights our commitment to developing exceptional quality and safety for our neonatal monitoring device.

ISO 13485 is an internationally recognized standard that sets requirements for a quality management system to ensure that organizations consistently meet customer and regulatory requirements applicable to medical devices and related services. Achieving this ISO 13485 certification demonstrates Rekovar’s ability to meet these regulatory requirements and consistently deliver devices that are safe and effective.

For healthcare providers and families, ISO 13485 certification assures that Rekovar’s neonatal monitoring kit is manufactured under controlled conditions, rigorously tested, and meticulously documented to ensure reliability and safety. This certification is crucial in maintaining high standards of performance and compliance with global regulatory frameworks.

From BSI’s website:

“Patient safety is at the very heart of ISO 13485, with its main purpose being to ensure the consistent design, development, production, storage and distribution, installation or servicing and disposal of medical devices. ISO 13485 requires organisations to implement these processes in accordance with identified applicable regulatory requirements for the markets they intend to operate in.”

At Rekovar, achieving ISO 13485 certification is not just a milestone, but a reflection of our ongoing commitment to quality, safety, and customer satisfaction. We will continue to uphold these standards in all aspects of our operations, ensuring that our medical devices contribute to improved patient outcomes.