EU MDR Consulting for Medical Device Software Compliance
What we offer
Comprehensive gap analysis to identify gaps in your product's compliance with EU MDR 2017/745
Development and improvement of Technical Documentation aligned with Annex II and Annex III of EU MDR
Guidance on Classification and Conformity Assessment for your medical device or software
Preparation and review of clinical evaluation reports (CERs) and performance studies
Integration of MDR requirements with Quality Management Systems (ISO 13485) and Risk Management Processes (ISO 14971)
Support in implementing Post-Market Surveillance (PMS) and Vigilance systems
Practical training for your team on MDR compliance requirements and their implementation
Assistance in preparing for Notified Body audits and obtaining CE certification
Why Work With Us
We have extensive experience navigating the complexities of EU MDR, ensuring your medical device software achieves compliance without unnecessary delays.
Our team has successfully guided multiple products through CE certification, leveraging practical expertise to streamline the process.
We prioritise clear, logical documentation and processes that integrate seamlessly into your current workflows.
We simplify the compliance journey, enabling your team to focus on product innovation and delivery.
Our approach ensures that your product remains compliant throughout its lifecycle, including post-market obligations.
To Whom Does EU MDR 2017/745 Apply?
EU MDR applies to all manufacturers and suppliers of medical devices, including software that meets the definition of a medical device. This includes:
Standalone software classified as a medical device, such as diagnostic or monitoring applications.
Software integrated into medical devices to perform specific medical functions.
Connected health solutions that gather, process, or analyse medical data.
Why Should Companies Comply with EU MDR 2017/745?
Compliance with EU MDR is mandatory for marketing medical devices within the European Union. Beyond meeting regulatory requirements, compliance ensures that your products:
Meet the highest safety and performance standards to protect patient health
Gain CE certification, which is required for market access in the EU
Build trust with patients, healthcare providers, and regulatory bodies
Avoid financial penalties, product recalls, or market restrictions resulting from non-compliance
Align with evolving regulatory and market demands, ensuring long-term product success
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