Regulatory

Our experienced design engineers and regulatory professionals are conversant with all major safety standards required by the regulatory bodies for medical product design and medical device design. ITL can undertake submission of instruments and devices for CE marking in accordance with the Medical Device Directive (93/42/EEC), In-Vitro Diagnostics Medical Devices Directive (98/79/EC), Low Voltage Directive (72/23/EEC), and the Electromagnetic Compatibility Directive (2004/108/EC) as applicable. We also offer an equivalent service for the North American market. We can aslo offer consultancy in medical regulatory compliance.