Comprehensive quality management and regulatory compliance for your device
We maintain a Quality Management System to control the design, development and manufacturing processes for products entering into worldwide markets
This system incorporates appropriate quality gates throughout the design and manufacturing process from supplier selection and qualification, through to final acceptance, device tracking and device maintenance.
ITL works closely within the appropriate European CE marking directives including:
- 93/42/EEC Medical Device Directive
- 98/79/EC In-Vitro Diagnostics Directive
- 2006/95/EC Low Voltage Directive
- 2004/108/EC Electromagnetic Compatibility Directive
- 2011/65/EU RoHS II Directive
Medical device regulatory consultancy
We also offer medical device development and regulatory consultancy, including pre-compliance safety and regulatory assessments, to assist you in your medical device product development project.
We have considerable experience in supporting our customers to achieve American Food & Drug Administration (FDA) 510k and Pre-Market Approvals (PMA).
Our Chinese facility also facilitiates China Food & Drug Administration (CFDA) applications.
Furthermore, we can help you to manage submissions and on-going factory audits for Nationally Recognised Testing Laboratories (NRTLs) including UL, CSA, ETL and MET (for US and Canadian market approval).