Our team of seasoned experts brings a wealth of regulatory expertise and industry knowledge to ensure the compliance of your medical device or combination product.
We understand that every project and its requirements are unique which is why we offer a range of expert commercial, regulatory and product development services at all stages of the journey to bring your medical device to market.
Our services include
Regulatory strategy to help you to navigate the complexities of US, EU and UK regulations, working with you to implement your regulatory strategy for a clear and timely pathway for market access of your medical device.
Classification strategy to help you to determine your product classification, devise conformity assessment routes to meet the essential requirements based on the classification of your device and provide an expert regulatory compliance strategy.
EU MDR navigation. Boyds closely monitors the activities and guidelines of the regulatory authorities and has a strong understanding of the recent developments of the new EU medical device regulations (MDR). We can assist you in your medical device development and answer any questions. Read our article in Medtech Innovations: Regulation for medical devices: recent developments explained.
QMS assistance and support to help you establish an appropriate quality system, ensuring your device is fit for purpose, effective, safe, and complies with regulatory requirements.
Technical file preparation and advice ensuring you have included the appropriate content for your technical files.
Notified Body and agency interactions working with you to act as an intermediary with the notified body or regulatory authority on your behalf.
Drug device combinations to help you navigate the complex interface between drugs and devices, drawing on our wealth of experience in medicinal products.