Product Safety and Regulatory Compliance

Our experienced design engineers and regulatory professionals are conversant with all major safety standards required by medical, diagnostic, analytical and scientific instrumentation regulatory bodies.

This wealth of experience can be called upon to advise on the 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/EEC), Low Voltage Directive (72/23/EEC), and the Electromagnetic Compatibility Directive (89/336/EEC) as applicable. We also offer and equivalent service for the North American market.

ITL offers the complete regulatory service to provide the client with a product which is ready to meet the market needs and satisfies all regulatory demands through:

• Definition of market requirements
• Design to meet regulatory requirements
• Initial design control
• Product configuration traceability through the Engineering Change Control system
• Formulation and maintenance of Technical Files
• Involvement with notified bodies for CE marking
• Involvement with known test houses for EMC and safety (eg 61010) testing
• Self-certifying compliance CE marking

Manufacturing your product at ITL means:

• A fully controlled post-design service
• On-going management of product certification
• Management of surveillance visits by external agencies and auditors