Regulatory Consultancy

ITL is able to offer the services of our highly-professional Regulatory Affairs Team to act as your consultants. In this capacity we are able to assess the current status and work required to achieve certification compliance for world markets.

Initially the team will liaise with you to define the requirements and obtain a broad overview. The time and effort required from ITL consultancy will depend upon the level of complexity of the instrument / device and the regulatory compliance necessary to achieve market approval.

The results of such a consultancy phase will be fully documented in a report outlining the requirements for compliance and engineering changes, should any be necessary. The time scales and cost estimates for achieving the changes will also be provided.

ITL is then able to assist by undertaking any engineering changes required to remedy identified non compliances. Subsequently ITL is able to offer a service to steer and manage the product through the testing process to attain certification and / or compliance with relevant EEC Directives or North American approvals applicable to the product.

The regulatory team at ITL is fully conversant with the requirements of the MDD and IVDMDD for all classifications and has the capability to guide you through the complex requirements necessary to obtain CE marking and FDA approval.