EU MDR 2017/745 Compliance Consultants

Elevating Standards, Ensuring Safety

The EU MDR introduces stringent requirements for medical device manufacturers, including enhanced clinical evaluations, rigorous post-market surveillance, and increased accountability.

Understanding and implementing these changes is crucial for market entry and success in the European market. MedLaunch provides expert guidance and strategic support to address these changes, helping your medical devices comply with new regulations while setting a benchmark for industry excellence.

Your Strategic Partner in EU MDR Readiness

MedLaunch provides start-to-finish support to help your organization meet EU MDR requirements:

• Gap Analysis and Strategic Planning: We begin with a thorough assessment of your current compliance framework compared to EU MDR requirements. Our experts develop a customized strategy that addresses gaps and aligns with your business objectives, facilitating a smooth transition to EU MDR compliance.
• Technical Documentation Enhancement: The backbone of EU MDR compliance lies in comprehensive technical documentation. MedLaunch aids in the preparation and review of all necessary documentation, including clinical evaluations, risk assessments, and quality management systems, to meet the strict standards of the EU MDR.
• Post-Market Surveillance System Implementation: A key element of the EU MDR is the emphasis on post-market surveillance and vigilance. We assist in setting up robust surveillance systems that facilitate ongoing compliance and rapid response to any market or regulatory changes.
• EU MDR Training and Organizational Support: Understanding the EU MDR is critical for your team’s success. MedLaunch offers targeted training sessions and continuous support to equip your staff with knowledge of EU MDR requirements and best practices.

Towards a Future of Enhanced Medical Device Safety and Innovation

Embracing the EU MDR is essential for medical device manufacturers aiming to enter or continue their presence in the European market. MedLaunch stands ready to be your strategic partner in this journey, combining regulatory expertise with a commitment to excellence, to overcome the complexities of the EU MDR together.