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Plastic components and assemblies for pharma and medical, under certified conditions

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A developing area

Pharma & Medical

For over ten years Scame Mastaf has produced components in which a non-conformity is not a cosmetic defect but a functional risk. In 2026 we completed the certification portfolio that brings that capability into the pharmaceutical and medical sector: ISO 13485 in March, UNI EN ISO 15378 shortly afterwards.

This page sets out what we are able to do today, under which certifications and with what documentary evidence. It contains no promises about capabilities we do not yet have.

We review your design for manufacturability at no cost: we look at geometry, material and process and tell you what can be improved before the design is closed. If complex engineering changes or a CAD redesign are needed, we quote that work separately.

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Detail of the Scara automation cell

The certifications covering this area

Standard Scope Body Issued Sites Document
UNI CEI EN ISO 13485 Medical device quality management system ICIM 31/03/2026 Suisio PDF
UNI EN ISO 15378 Packaging farmaceutico primario — GMP IIP 22/09/2026 Suisio PDF
ISO 9001:2015 Quality management system IIP 01/12/1997 Suisio · Bovezzo · Vertova PDF
ISO 14001:2015 Environmental management system IIP 19/05/2025 Suisio · Vertova PDF
ISO 45001:2018 Occupational health and safety IIP 21/02/2020 Suisio · Bovezzo · Vertova PDF

We are the right supplier if

  • you need moulded components and assemblies in industrial volumes, not one-off prototypes;
  • you work on Class I and IIa devices, in vitro diagnostics, medical instrument housings or plastic primary pharmaceutical packaging;
  • you need co-design and industrialisation, not just a quotation against a finished drawing;
  • your qualification process includes supplier audits and you want the documentation ready when you arrive.

We are not the right supplier if

  • you need production in an ISO 14644 certified cleanroom: it is under assessment in our roadmap and is not available today;
  • you need production or packaging in a sterile environment;
  • you are looking for a supplier of active pharmaceutical ingredients, formulation or fill-finish services.

What you can request before an audit

We respond to documentation requests within two working days. On request, and subject to an NDA where necessary, we make available:

  • a public extract of the Quality Manual;
  • the GMP procedures applied in production;
  • sample IQ/OQ/PQ validation records and SPC plans;
  • the change control procedure;
  • the roadmap of certifications in progress;
  • the Sustainability Report and the Code of Ethics.

If you prefer to see for yourself, we can arrange a visit to the Suisio plant: three hours, in Italian or English, with the multi-colour cell running, the automation cell, the Industry 4.0 toolroom and quality control.

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