Regulatory1 provides complete “One Stop Shopping” support for the Market Approval (MA) of Medical Devices and IVD’s. We also provide training in all aspects of the development and regulatory process.
Regulatory1 Consultancy advises and supports the organization during implementation and with maintenance of your quality management systems, through to all activities concerning applications for and preservation of registrations world-wide, and/or the required audits.
We offer a unique “One Stop Shopping” approach, supporting medical device manufacturers to achieve compliance with global regulatory requirements. For regulatory submissions, it is key to choose the right order of markets to enter. The success of application depends on the correct tailoring of the technical documentation for submission purposes.
Our in-house expertise on determining the appropriate global regulatory market entry strategy and can support in preparing submission files which comply to specific local regulations. Whether it relates to listing your devices in databases or filing complete regulatory submissions (i.e. CE submissions, FDA submissions), our experts are ready to assist.