Short introduction

Zelemiq is a design technology company that provides product design and regulatory affairs input to companies working in the medical sector

Company Description

Here at Zelemiq it is our aim to offer a truly unique service to our clients. We specialise in new product design for regulated industries. We understand that taking proper account of the regulatory affairs is every bit as important as the actual design when developing a new product. We bring our experience to help you get your next innovative products to market. Zelemiq Medical Product Design Services can help you develop you next Medical Device, we understand Regulatory Compliance so know how to work with you within your 13485 Quality System to ensure compliance success for CE marking and FDA approvals. Zelemiq ATEX Product Design Services specialises in developing products used for explosive environments for the Gas and Oil industry. Zelemiq Process Control Services specialises in developing manufacturing measuring and control systems for production lines and processes. Product Design for your Business Zelemiq can offer a full product design service for anything from your next medical device to industrial process control equipment. Our specialist team of engineers, software developers and product designers are ready to get going on your next project. We are able to offer help and advice with achieving regulatory compliance for your product. Some clients will chose to involve us for the entire product development cycle, however we understand that sometime all you need is a few days consultancy to steer your path through this process from time to time. Please get in touch to discuss your requirements. Our aim is to help you to innovate your way to a world beating product. Medical Devices and Regulatory Approval It is vitally important that proper regard is paid to following the relevant regulatory affairs when developing a new medical product. It can be difficult to identify the correct standards and guidance to use, and interpreting and understanding the them can present another level of difficulty. At Zelemiq we offer just the amount of help and support with this you need. This can start with helping to identify where your product sits within the regulatory framework, identifying which standards and guidance applies. If required we can also take on the product design work to take your idea and tern it into reality. Again we can do as much of this or as little as required, some clients want us to do the entire product, while others only need us for one particular aspect of a design. We can help you with your verification and validation testing to ensure compliance to the regulations. Finally Zelemiq can help you to get you product into production and onto the medical market. We can guide you through the processes of registering your product and obtaining approvals for CE marking and FDA 510(k) applications. Production Process Control and Test Equipment Zelemiq can design and build out of the ordinary measurement and control systems for production process control. We specialist in developing solutions for new or difficult to control processes where no off the shelf solutions exist. We will take the time to understand your requirement and work with you to achieve the measurement and control system you require. We can design and develop test equipment for one off compliance testing or for incorporation into a product line.