Your Trusted Partner For Safe And Compliant Medical Devices
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IntroductionWith LITERO, you gain expert guidance, regulatory and quality confidence, and market success for your medical devices. Let’s navigate the path to compliance and quality together.
Clinical Evaluation Plan and Report
LITERO supports you in developing a comprehensive clinical strategy and reviewing your claims. We prepare the clinical evaluation, including the plan and report, and, if necessary, create the SSCP. Our goal is to assess the benefit-risk ratio of your medical device and define measures to ensure this ratio remains positive and acceptable in the long term.
Regulatory requirements
We provide comprehensive support for the approval of medical devices in Classes I to III, guiding you through the entire process in compliance with the requirements of the MDR (Medical Device Regulation).
From conducting the appropriate conformity assessment procedure to assisting with the preparation and thorough review of the technical documentation, we ensure that your product fully meets all regulatory requirements. Additionally, we offer support in communicating with Notified Bodies and help you effectively overcome potential hurdles in the approval process. Our goal is to facilitate the market authorization of your products efficiently and securely, providing expert guidance every step of the way.
PSUR & PMCF
We prepare and update your PMS plan in accordance with the requirements for post-market surveillance and vigilance. The results and conclusions of the benefit-risk analysis are summarized for you in the PMS report or PSUR. Additionally, we support you in planning and implementing your PMCF activities and document the outcomes in a detailed PMCF report. This ensures that your medical device continues to comply with regulatory requirements and is effectively monitored even after market launch.
ISO 13485 and MDR
The PRRC ensures that your company complies with all MDR requirements, including conformity assessment, adherence to the quality management system, and technical documentation. Additionally, the PRRC oversees post-market surveillance and reporting obligations to identify potential risks early and implement appropriate measures. We offer you the opportunity to delegate this crucial role to an external PRRC expert, allowing you to focus on your core business while ensuring full compliance with all regulatory requirements.
ISO 13485 and MDR
In the field of medical technology, ISO 13485 is the recognized standard for an effective quality management system, as medical devices must meet specific requirements. Additionally, the General Safety and Performance Requirements of the MDR must be considered to ensure product compliance and safety.
We provide comprehensive support in developing your quality management system in accordance with ISO 13485 and the MDR regulations. Together, we create tailored and efficient processes that comply with applicable standards. Furthermore, we conduct internal audits to ensure consistent adherence to high-quality standards.
Chance for your development
We offer tailored personnel training that can be conducted either remotely or on-site. Our programs cover clinical, regulatory, and quality requirements, as well as SOPs for medical devices. Each training session is customized to align with your specific products and needs, ensuring your team is well-prepared to meet the current challenges in medical technology.
The ever-changing landscape of medical device quality, regulatory, and clinical requirements demands expertise and precision. LITERO is your partner in overcoming complexity, ensuring your product reaches its full potential.
Essener Straße 4, Building D3
22419 Hamburg
Germany
+49 176 84620065
info@litero-agency.com
