Medical devices

The Community directives and the Italian legislative provisions transposing them govern, separately, three categories of medical devices:

active implantable medical devices ((Directive 90/385/EEC; Legislative Decree no. 507 of 14 December 1992)
medical devices (in general) (Directive 93/42/EEC; Legislative Decree No. 46 of 24 February 1997)
in vitro diagnostic devices (Directive 98/79/EC; Legislative Decree No 332 of 8 September 2000)

Pharmintek offers support for:

Management of regulatory affairs:

We offer regulatory support to all actors in the supply chain in compliance with labelling, notification, normal and/ or simplified, production according to the standards defined at European level, the preparation of the technical dossier.

Preparation of the Technical Documentation:

We support the company in the preparation and preparation of the necessary documentationfor the preparation of the Technical Dossier.

Production:

We support the customer in the revision, development and implementation of the quality manual, for the production and for obtaining and maintaining the authorization to produce particular foods

Medical devices

The Community directives and the Italian legislative provisions transposing them govern, separately, three categories of medical devices:

Pharmintek offers support for:

Management of regulatory affairs:

Preparation of the Technical Documentation:

Production:

Rely on our

Training

Courses and workshops are carried out by Pharmintek, at the customer’s premises.

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Contacts

Hours to the public

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