Ensuring EU Medical Device Regulatory Compliance with Expert Technical File Updates
MD Compliance is your dedicated partner for navigating and meeting the requirements of the EU Medical Devices Regulations 2017/745 and IVD Regulation 2017/746. Navigating the complexities of the MDR and IVDR requires a meticulous approach to technical documentation. We know what the Notified Bodies are looking for and will help you to create all the Technical Documentation your product will require to meet the latest requirements. For your legacy products certified under the previous MDD or IVDD, our Technical File update service is designed to keep your medical device documentation current, ensuring compliance and market access. And, as you would expect, we have the expertise you need to ensure your medical devices meet all applicable UKCA requirements, too!
Our Technical Documentation Services
Technical Documentation Creation
Ensure a robust technical file that comprehensively demonstrates compliance with MDR and IVDR requirements.
Clinical Evaluation Reports
Benefit from in-depth clinical evaluation reports that align with the latest regulatory expectations.
Risk Management Documentation
Mitigate risks effectively with meticulously crafted risk management documentation.
Post-Market Surveillance
We will help you maintain a post-market vigilance system with thorough, pro-active surveillance documentation needed to demonstrate fulfilment of your regulatory obligations.
Labelling and Instructions for Use
Craft clear and compliant labelling and instructions for use that enhance user understanding and safety.
Regulatory Expertise
Stay ahead of regulatory changes with our team of experts. We meticulously review and update your technical files to align with the latest EU Medical Devices Regulations, guaranteeing compliance and smooth market access.
Comprehensive Documentation Review
Our experienced professionals conduct thorough reviews of your technical files, identifying gaps and ensuring that all required documentation meets the stringent standards set by EU regulations.
Timely Updates for Compliance
Regulatory changes happen, and we ensure your technical files are promptly updated to reflect any modifications in the EU Medical Devices Regulations. Stay compliant and maintain market authorization seamlessly.
Why Choose MD Compliance?
Regulatory Prowess
Benefit from our in-depth understanding of EU Medical Devices Regulations and stay confident in your compliance.
Tailored Solutions
We recognize the unique aspects of your medical devices. Our services are customised to address your specific technical file requirements.
Efficiency and Accuracy
Trust us to deliver efficient and accurate updates to your technical files, minimising the impact on your operations.
Continuous Support
Regulatory compliance is an ongoing process. We provide continuous support to keep your technical files up-to-date and aligned with evolving regulations.
Our PMS Services
MDR and IVDR Post-Market Surveillance Support
Navigate the complex landscape of post-market surveillance with confidence. Our dedicated team provides tailored support to ensure your medical devices and in vitro diagnostic products comply with the latest regulations.
PMS Planning
Craft robust post-market surveillance plans aligned with MDR and IVDR requirements. We understand the complexities involved with ensuring PMS, Risk Management and Clinical Evaluation remain interlinked, and help you establish effective strategies for monitoring and assessing your products throughout their lifecycle.
Data Analysis and Reporting
Our experts analyse post-market data to identify trends, potential issues, and opportunities for improvement. We provide comprehensive reports to meet the reporting obligations outlined in both MDR and IVDR.
Regulatory Review and Strategic Planning
We have experience assisting customers with a comprehensive review of the status of their product portfolio in multiple markets and regulatory jurisdictions. We can assess your current situation, identify existing (and potential) gaps, and provide a written report with targeted recommendations. Contact us today to discuss your needs!
