According to EU regulations for manufacturers which are not directly established in the Union, the authorized representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person in the European Union.As your authorized representative, we undertake various responsibilities on your behalf. These include:
1. Maintenance of Technical Documentation: We manage and maintain the technical documentation required for compliance with EU regulations. This includes ensuring that the technical file is up-to-date and accessible to relevant authorities upon request.
2. Responding to Regulatory Inquiries: We function as the point of contact for regulatory inquiries from EU authorities or other relevant stakeholders. This involves promptly addressing any queries or requests for information on your products or compliance status.
3. Hosting Audit Committees: In case of an audit or assessment by regulatory authorities, we facilitate the process by providing logistical support and hosting the audit committee if required. Our goal is to ensure a smooth and efficient audit process that proves your commitment to compliance.
By appointing us as your representative in Europe, you can rest assured that your compliance obligations are met with diligence and professionalism. We offer comprehensive support tailored to your specific needs, allowing you to focus on your core business activities while we manage the regulatory requirements on your behalf.