An ISO:13485 certified in-house team and range of regulatory specialists working to the latest standards.

Haughton Design is fully certified to ISO 13485:2016 so fully understands design controls and the regulatory requirements for both HD and our clients. We are predominately a design, engineering and development team so don’t profess to be experts in all aspects of regulatory requirements, compliance and quality management systems across all segments of the med tech and pharma industries. Therefore, HD has a number of pre-approved associate consultants who are experts in specific fields of the medical device regulations for Europe and the US. For general products and equipment we can help with the CE marking process.

By working collaboratively with our clients and our associates we are able to identify the most appropriate experts, then develop solutions to comply with the relevant standards for the territories in which your device will be sold. This approach ensures up to date advice and guidance for MDR and FDA requirements to ensure an efficient route through the development process and launch of the device or product.  We are extremely flexible in our approach so for those clients who require it, our consultants can work directly with you to deal with your project’s regulatory and CE marking requirements too.

Having this safety net is invaluable as it allows us to concentrate on design and development. Using this approach means our regulatory consultants ensure we, and if it helps, our clients work to the latest standards and best practices throughout a project.

If you are encountering difficulties, need expertise, resource, or have a problem to solve then please give us a call, we will always try to help.

Our Latest Thinking & Work in Regulatory Advice & CE Marking