Competencies - Stevanato Group
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Our Competencies

In an ever-changing world, we keep our sights firmly fixed on Today and Tomorrow.

Without being rigid in our thoughts and actions.

Not limiting horizon and range of action.

For us, stability is synonymous with agility, interest turns into highest esteem.

We act in a creative and structured manner, we blend innovation with systematic project management.

We support by scrutinizing, reflecting, lateral thinking – We are your one-stop solution provider.

Product Development

 

  • Development of ideas to final serial products
  • Development of sustainable solutions in close dialogue with the customer (CDMO)
  • Market driven in-house developments
  • Systematic, function-oriented development approach
  • Design work based on sound manufacturing know-how, proven production experience
  • Regulatory approved development process
  • Modular, reliable service throughout the product life cycle

 

Process development & production

  • Reliable and economic production of components and systems according to GMP and cGMP regulations
  • 24/7 production in controlled areas and clean rooms (e.g. ISO 8 and ISO 7)
  • High precision injection molding technologies
  • Fully-automated assembly and linked processes
  • Finishing technologies for decorated and functionalized surfaces
  • In-line inspections
  • Tailormade packaging
  • Preventive maintenance

 

Quality

  • Quality management System according to ISO 15378, ISO 13485 and 21CFR820
  • Six-Sigma approach throughout the entire industrial product life cycle
  • Sustainable qualification and validation process (DQ, IQ, OQ, PQ)
  • Thorough risk management system
  • Experience in product registration (CE and FDA)
  • State-of-the-art measuring technologies with computer tomography, tactile and optical measurements

 

Project Management

  • Point of contact to the customer throughout Industrialization Phase and Serial Production
  • Dedicated responsibility for the assurance of quality, time and costs within the industrialization project
  • Consideration of specific customer requirements like bioburden, shipping validation or shelf life

Scope:
Development and production of plastic components and products for pharmaceutical, diagnostic
and medical appliances.
Through an audit, documented in a report, it was verified that the management system
fulfills the requirements of the following standard:
ISO 9001 : 2015

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Scope:
Development and production of plastic components and products for medical appliances.
Through an audit, documented in a report, performed by DQS Medizinprodukte GmbH, it was
verified that the management system fulfills the requirements of the following standard:

DIN EN ISO 13485 : 2016 + AC : 2017-07
EN ISO 13485 : 2016 + AC : 2016
ISO 13485 : 2016

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Scope:

Development and production of plastic primary packaging materials for medicinal products.

Through an audit, documented in a report, it was verified that the management system

fulfills the requirements of the following standard:

DIN EN ISO 15378 : 2016

ISO 15378 : 2015

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Scope :Development and production of plastic components and systems for the market segments of pharmaceuticals, diagnostics and medical technology
Proof has been furnished by means of an audit that the requirements of BS OHSAS 18001:2007 are met.

BS OHSAS 18001:2007

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Scope: Development and production of plastic components and systems for the market segments of pharmaceuticals, diagnostics and medical technology
Proof has been furnished by means of an audit that the requirements of ISO 14001:2015 are met.

ISO 14001:2015

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Scope: Development and production of plastic components and systems for the market segments of pharmaceuticals, diagnostics and medical technology
Proof has been furnished by means of an audit that the requirements of ISO 50001:2011 are met.

ISO 50001:2011

READ THE CERTIFICATE

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