LM4med
Our DNA? Innovation.
Our Mission? Ensuring the safe and swift approval of your products.
At LM4med, we prioritize innovation and efficiency to bring your medical devices to market safely and quickly. As a Legal Manufacturer, we offer tailored services covering everything you need for product approval and success. From the initial concept to market launch, we support you at every stage.
We assist our clients in successfully navigating the complex approval process under European regulations, particularly MDR and In Vitro Diagnostics.
LM4med provides support in areas such as preparing the required technical documentation, conducting conformity assessments, managing clinical studies, and post-market surveillance. We also handle communication with notified bodies.
Our expertise in regulatory affairs, approval consulting, production, and lifecycle management ensures that your products meet the highest quality standards and comply with all regulatory requirements. Trust our experience, and let’s pave the way to your success together!
SERVICES
We are the specialists when it comes to bringing highly complex devices to market!
Learn more:
LEGAL MANUFACTURER
- Consulting and support for the approval of medical devices
- Execution and guidance of approval processes (MDR/IVDR, FDA)
- Market monitoring and vigilance
- Preparation of the medical device file, including risk management
- Ensuring compliance throughout the entire product lifecycle
- Support in market launch and post-market surveillance
CONSULTING
- Tailored consulting throughout the entire development process of medical devices
- Support in creating requirement and specification documents
- Guidance on design transfer and regulatory compliance
- Assistance with market launch and product monitoring
- Support in clinical evaluation and lifecycle management
- Guidance in risk assessment and analysis
DEVELOPMENT
- Support in design and development processes in compliance with MDR/IVDR and FDA regulations
- Requirement engineering and system architecture design for medical devices
- Development of hardware, software, and systems for medical devices
- Implementation of risk management and usability plans
- Execution of tests and verifications according to regulatory standards
- Guidance through the entire development process, from concept to market-ready product
PRODUCTION
- Optimization of the design transfer phase for efficient production
- Transitioning development projects into series production
- Sourcing strategies and establishing second-source options
- Conducting process FMEAs and value stream analyses
- Development and implementation of lean concepts for manufacturing logistics and assembly processes
- Contract manufacturing of components and complex medical devices
- Setup of test workstations and development of acceptance test processes