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 product, which involves proper compilation of detailed information about design, function, use, claims, and clinical evaluation of the medical device. The other part of the conformity assessment is to demonstrate that you comply with legal manufacturer obligations as defined in applicable in medical device jurisdiction. These processes are critical steps in the product development process of a medical device.
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.
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.
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