Legal Manufacturer
LM4med is your reliable partner for comprehensive regulatory support as a Legal Manufacturer.
Our approach as “Legal Manufacturer as a Service” provides you with a complete solution to safely and compliantly introduce products to the European market in accordance with the strict requirements of the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation). We take on the role of the manufacturer for your product, without producing or developing it ourselves, ensuring that all regulatory requirements are met. This allows you to focus on your core competencies while we handle all legal and regulatory obligations for the EU market, including communication with Notified Bodies and authorities.
Leistungen
Consulting on EU-wide approval requirements, tailored to the specific needs of your product.
Detailed analysis of the relevant legal regulations for your medical device.
Comprehensive management of regulatory processes and documentation to ensure compliance.
Support in obtaining the necessary certifications for the European and American markets.
Support throughout the entire market launch process, from the initial conformity assessment to product approval.
Continuous market monitoring and product surveillance to ensure the safety and compliance of your products even after market introduction.
Authorized Representative (EU-REP) for Market Introduction
As an EU Representative (EU-REP) for manufacturers outside the European Union, we act as your legal representative and take on all the tasks required for the marketing of medical devices in the EU. LM4med serves as the official point of contact for European authorities and ensures compliance with all relevant regulations.
Our role as EU REP includes:
Direct point of contact for European authorities and surveillance bodies to ensure effective communication.
Management and storage of all technical documents, which must be available at any time for inspections and audits.
Verification and confirmation that all products comply with EU regulations before being brought to market.
Monitoring of product performance after market launch and handling of any corrective actions or recalls in close cooperation with manufacturers.