Menu Home » Services » Regulatory Regulatory Your trusted and focused solution partner since 1923 RELATED ARTICLES Quality in the medical device industry by Malin Gustavsson Are you ready for the Medical Device Regulation (MDR) 2021? by Tina Friis Poulsen Read all of our blog articles > This post is also available in: 简体中文 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 Competence in Guiding and Supporting within the Regulatory Field PRESS RELEASES & REGULATORY INFORMATION Elos Medtech Interim Report January 1 - September 30, 2021 20 Oct 2021, 08:00 Financial / IR information SHARE TICKER Elos Medtech B (ELOS B) Latest +/- % Ask Bid 340 5 1.49 335 327 Last update: 24 November 2021, 2:31 STAY UPDATED! Subscribe to our newsletter SUBSCRIBE Copyright © 2021 by Elos Medtech AB. All rights reserved. Cookies & Privacy Policy Follow us: This website uses cookies to provide you with the best browsing experience. Find out more or adjust your settings. Accept