More comprehensive medical device development, from concept to market.
NorthSky Design are specialists in medical device development, product design, engineering and manufacturing. We work with businesses to turn ideas and opportunities into commercially viable, manufacturable products.
Our exclusive collaboration with Medilink North of England strengthens this capability, giving our clients access to specialist regulatory, clinical, quality and commercialisation expertise alongside our product development and manufacturing services.
From initial opportunity and concept development, through engineering and regulatory, to manufacturing and ongoing support, we can help coordinate the expertise required to move a product forward.
Combining Complementary Expertise
Successful medical device development requires different areas of expertise to work together. Design and engineering decisions can have a significant impact on regulatory requirements, clinical evaluation and ultimately the commercial success of a product.
By combining NorthSky’s product development expertise with Medilink’s specialist knowledge, we can bring the right expertise into a project at the right stage.
Specialist Regulatory Support
As part of this new collaboration, we can connect clients with Medilink’s specialist regulatory services, including regulatory advice, MDR and IVDR support, technical file gap analysis and Clinical Evaluation Report (CER) writing.
Bringing regulatory expertise into the development process early, we can help identify requirements before they become costly problems, ensuring that the product is developed with its intended regulatory pathway in mind
One connected development service
Our collaboration with Medilink allows NorthSky to offer clients a more complete medical device development and manufacturing service.
NorthSky brings the product to life. Medilink helps navigate the pathway to market.
Together, NorthSky and Medilink provide a joined-up approach to medical device development that reduces complexity for our clients and gives them access to specialist expertise throughout the product journey.
