The production process validated by the US Food and Drug Administration

Thanks to their quality system and mastery of the production process, Serviplast Industrie assembles and packages electro-stimulation medical devices.

By mastering its processes, Serviplast Industrie ensures the traceability of products from reception to shipping

A medical device – like all medical devices – is governed by strict rules concerning traceability. Traceability methods are specified by the regulations in effect and aim to ensure the safety of patients. As a result, the methods must be strictly adhered to; if not, heavy sanctions apply.

Serviplast Industrie is used to strict limitations with respect to traceability. Serviplast Industrie assembles and packages products for Cefaly Technology, a Belgian company that produces and distributes a medical device for treating and preventing migraines.

Before assembling cases, buttons and printed circuits, Serviplast Industrie ensured a foolproof traceability process. The team adapted quickly; they already had the knowledge, the expertise and the necessary resources to assemble and package medical devices.

As a result, Serviplast Industrie ensured:

• lthe traceability of all the components;
• the traceability of product units: each product has a specific number that is linked to the batch of components;
• the traceability of the entire chain.

Thanks to their mastery of these processes, Serviplast quickly set up a system for packaging the device while meeting deadlines.

Cefaly Technology organises logistics for its customers and distributors from Serviplast Industrie. Serviplast’s Industrie logistics department handles the operational aspects.

In order to deliver medical products to the United States, Serviplast Industrie had to pass quality audits administered by an agent of the US Food and Drug Administration.

Serviplast Industrie passed the quality-control audit with flying colours! As a result, Serviplast Industrie satisfies the regulatory requirements with which medical device customers must comply.

A comprehensive, stress-free offer

Thanks to Serviplast Industrie, Cefaly Technology is assured:
– that they will save time, by having a single partner who centralises the assembly, packaging and shipping processes;
– of quality control that passes strict FDA audits with flying colours;
– of a suitable storage location to manage the storage of components and finished products

… all headache-free!

Are you active in the medical or paramedical field? Would you also like to receive a bespoke offer? Contact our team!