Medical Devices
Expert Support for Medical Devices Compliance and Innovation
Elevating Patient Safety and Product Effectiveness
At QAEC Limited, we’re dedicated to advancing the quality and regulatory compliance of your medical devices. Whether you’re bringing a groundbreaking product idea to life or enhancing an existing product, our expertise in Quality and Regulatory affairs ensures your medical devices not only meet compliance standards but also safeguard patient safety and achieve their designed purpose and use.
Navigating the complexities of regulations, classifications, and standards within the medical device industry can often seem daunting. That’s where we step in. Our team is committed to demystifying these challenges, offering you the guidance and support needed to navigate the regulatory landscape with ease.
Streamlining Processes for Efficiency and Success
Our comprehensive services include documentation maintenance, ongoing monitoring, and continuous improvement strategies. We’re here to assist you in ensuring full compliance and conformity with all relevant standards and regulations. By streamlining your processes, we aim to enhance your organisation’s efficiency, reduce operational costs, and boost your overall success rate.
Navigating EU MDR 2017/745 with Confidence
The transition from the Medical Device Directive (MDD) to the Medical Devices Regulation (MDR) 2017/745 represents a significant shift, requiring a deeper commitment from medical device businesses. Our team is well-equipped to clarify how this transition impacts your business and to guide you in defining a robust Regulatory Strategy. We offer comprehensive support for your submissions and ensure that your business processes and Quality Management Systems are perfectly aligned with both current and new products throughout their product lifecycle.
Let QAEC Limited be your partner in successfully managing the MDD to MDR 2017/745 transition, ensuring your medical devices are compliant, effective, and ready to meet the needs of the market.
Let’s Start a Conversation
Ready to take the next step towards compliance and market success? Contact us at 01452 341913 or enquiries@qaeclimited.co.uk to discuss how we can support your medical device projects.
Or for a deeper exploration of how our services can be tailored to your unique needs: