Medical devices
In developed international markets, the challenges faced by developers and promoters of medical devices are governed by some of the most detailed and extensive regulations in the sector. From the diverse range of innovations and technologies that may be classified as medical devices to patient information rules and health information technology regulations, the regulatory burden on stakeholders in this market is substantial and rapidly evolving. Expert guidance is crucial, especially when operating across borders where technological advancements often outpace regulatory developments.
Our team includes not only regulatory specialists experienced in all aspects of the medical device lifecycle but also lawyers with backgrounds in science and engineering who offer a deep understanding of the underlying technology. This unique combination ensures that BLK Partners provides an unparalleled level of expertise and value in the regional legal market.
Examples of work undertaken by our lawyers includes advising on:
- Regulatory compliance issues concerning applications used in conjunction with diagnostic equipment
- Regulatory aspects of the development of an innovative technology used in phlebotomy services
- Protecting intellectual property relating to a novel surgical instrument
- The commercialization of a medical device designed to improve oral health