INNOVATION

In-house R&D

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

Our facilities have been awarded a AAMI (Association for the Advancement of Medical Instrumentation) Standards Extraordinary Achievement Award for design and analysis efforts which exceed the ISO 80369 series of standard.

DILIGENCE

Meticulous procurement

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.

COMPLIANCE

Patient safety first

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.

Our automated assembly lines boast 100% in-process quality controls and our manually assembly lines carry out controls at every stage of production. Over and above these in process controls, incoming inspection and final inspection prior to product release are routinely performed by qualified personnel.

EXCELLENCE

Injection moulding

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 clean rooms are ISO class 8 certified where we can work with a variety of raw materials including, but not limited to ABS, PP, LDPE, TRITAN, HDPE, PVC, PS, EVA and TPE.

AGILITY

State-of-the-art assembly

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.

FLEXIBILITY

Labelling & packaging

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.

TRUST

Registration

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.

REACH

Worldwide distribution

We have over 8’500m2 of warehouse space and ship to over 40 counties across the globe.

Our supply chain department is well-established and connected with major freight forwarders around the world. We place a strong emphasis on reliability and are committed to delivering in full and on time.

To accommodate desired lead times, freight terms and customs requirements, we are proficient in arranging a variety of shipping methods including truck, sea, and air freight.

Cedic S.r.l. Downloads

Enteral Access Medical Devices Product Catalogue

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