Cedic S.r.l. services

We have spent the last 50 years developing our internal R&D and Project Management capabilities of finished products and components which now comprise: Rapid prototyping via 3D Modeling & 3D Printing. Technical feasibility & assembly technology evaluation. Finite Element Analysis. Verification and Validation (V&V) in-house testing. Moulding process definition, optimisation & qualification. Assembly process validation (IQ, OQ, PQ). Statistical analysis, Design for Six Sigma approach. Knowledge of applicable ISO standards.

Ensuring only the best materials are sourced and sustainable packaging is used, our procurement department has evolved to be highly specialised in procuring for the medical devices industry. Clients can rest assured knowing that we utilise controlled sources from a long-standing network of credible suppliers. Our procurement colleagues also work closely with the many technical experts within Cedic to support specific project needs and foster product innovation with the necessary equipment and machinery.

We mould over 500 million components annually encompassing various areas of care with extensive capabilities including: ENFit® transition adapters, screw caps, spikes, administration set components, tube feeding connectors, enteral feeding caps, luer-lock connections.

Our sophisticated automated assembly lines ensure speed to market, consistent high product quality and cost effectiveness complete with 100% in-process quality control. While our manual assembly lines allow us to guarantee a high level of flexibility to accommodate a wide range of specific customer needs. These lines are set up to produce diverse range of sub-assembled products and finished medical devices.

Our Quality Management System (QMS) complies with ISO 13485 standard and is MDSAP certified for Australia, Brazil, Canada, the United States and Japan. Patient safety is guaranteed through product CE certifications, FDA clearance and compliance with the applicable ISO standards , such as ISO 14971 for conducting Risk Management. All this is strengthened by our robust QMS involving rigorous control procedures throughout the entire product lifecycle.

In-house customised packaging and printing capabilities with various print and design options to suit our clients’ needs. Our labelling operation is also equipped to automatically blister products of various shapes and sizes. What’s more, we are qualified to check the validity of labels and to validate EO sterilisation for our clients’ own products upon request.

We have the internal resources and expertise to file and maintain product registrations worldwide including FDA clearance and CE markings. Our experienced regulatory team is on hand to support our customers through the registration process from start to finish; from filing the application to labelling and proofing and are across the latest updates and requirements.