Ensure regulatory compliance for your medical devices

Speed to market depends significantly on thorough preparation for the required conformity assessment by Notified Bodies and competent authorities. One part is the preparations of technical documentation for the medical device, which involves proper compilation of detailed information about design, function, use, claims, and clinical evaluation of the medical device. The other part is to demonstrate that you comply with legal manufacturer obligations as defined in applicable medical device jurisdiction. These processes are critical steps in the product development process of a medical device.

We understand the regulatory requirements of the medical device market

Thanks to our vast experience as a trusted solution partner to leading companies in our selected markets, Elos Medtech understands the medical device market and its regulatory requirements. In the last ten years, we have also added our own products in selected markets, which have given us even broader insight and competence.

We guide you to compliance of your medical devices

When you work with us, we will guide you to regulatory and quality compliance with both international standards and country-specific requirements. Our regulatory services include well-established quality management processes and procedures including proper documentation to ensure compliance with adequate regulatory requirements.

Well-documented quality and environmental management system

Elos Medtech’s quality and environmental management system is well documented, and we are certified against standards and in compliance with medical device jurisdictions, including:

  • Environmental management system in accordance with ISO 14001:2015
  • Quality management system in accordance with ISO 13485:2016 and ISO 9001:2015
  • FDA (Food and Drug Administration) quality system regulations and GMP
Mobilizing our production sites in response to the acute global shortage of life-sustaining ventilators

Looking for an end-to-end CDMO?

We have developed a set of value-adding services with a successful track record of helping medical device companies worldwide improve their operations. Let us become your trusted partner.