The Context
As a trusted partner in the medical device industry, BONNER offers specialised expertise to support clients throughout the product life cycle. Our team possesses a deep understanding of the complex regulatory landscape, technological advancements, and market dynamics that shape the medical device sector. Whether you are a startup developing a revolutionary medical device, an established manufacturer seeking to enhance your product portfolio, or a healthcare institution looking to optimise device utilisation, with signification experience in the sector, we provide comprehensive guidance and support.
The Response
From concept development and prototyping to regulatory compliance and commercialisation strategies, we assist clients in navigating the intricate pathway of medical device innovation.
Our experts are well-versed in regulatory frameworks such as FDA and CE Marking requirements, ensuring that our clients meet the necessary standards for safety, effectiveness, and market access.
We provide strategic advice and support on product development, usability engineering, risk management, and clinical evaluation, helping our clients bring safe, effective, and innovative medical devices to market.
The Results
We provide support in conducting clinical evaluations, assessing the safety and performance of medical devices. Our team assist in designing and executing clinical studies, collecting and analysing data, and generating the necessary clinical evidence to support regulatory submissions.
Additionally, we offer support in post-market surveillance, including adverse event reporting, vigilance monitoring, and product life cycle management. Our expertise extends to emerging trends such as connected devices, digital health solutions, and artificial intelligence in healthcare.
By leveraging our knowledge and experience, we empower our clients to navigate the complex landscape of medical device regulation, optimise their product offerings, and deliver quality and value to patients and healthcare providers.
