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Contract Manufacturing Services

Quality and Regulatory Support for Medical Devices

Integrated quality framework for regulated medical products

Stevanato Group supports pharmaceutical, biotech, and diagnostics companies with quality and regulatory services embedded throughout the product lifecycle, covering drug delivery systems (DDS), disposable diagnostic (Dx) products, and combination products.

Our integrated model ensures products are manufactured, documented, and controlled in line with applicable medical device and combination-product regulations, from development through commercial supply.

Quality

Robust quality management systems

All contract manufacturing activities operate within certified Quality Management Systems, aligned with international and regional regulatory standards, including ISO 13485, ISO 15378, and 21 CFR Part 820 (QMSR) for U.S. operations. Manufacturing sites operate within inspected and audit-ready environments.

Our quality framework supports:

  • Controlled manufacturing and inspection processes
  • Full batch documentation and traceability
  • Change management and deviation control
  • Risk-based qualification and validation (DQ, IQ, OQ, PQ)
About Us

Regulatory support across the product lifecycle

Stevanato Group provides regulatory support services to assist customers throughout the development, industrialization, and commercialization phases of a project.

Services include:

  • 182_Key Takeaway

    Alignment of manufacturing and quality documentation with regulatory requirements

  • 274_Design

    Support for design transfer and industrialization readiness

  • 350_Procedures

    Contribution to regulatory submissions and technical documentation, where applicable

  • 354A_Z-Travel

    Support for biocompatibility studies, shipping validation, and stability testing

  • 154A_Operation Excellence

    Ongoing support for post-market changes and lifecycle management

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Inspection, documentation, and process control

Quality assurance is reinforced through systematic inspection, validation, and documentation practices for early detection of variability and sustained compliance during routine manufacturing.

Key elements include:

  • In-process controls and final inspection strategies
  • Validated inspection methods and documented procedures
  • Statistical Process Control (SPC) to monitor process stability
  • Data integrity and traceability across manufacturing stages
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Audit-ready operations and long-term compliance

Stevanato Group operates in regulated environments subject to regular internal and external audits and supports customers during regulatory inspections.

Our quality and regulatory teams work in close collaboration with manufacturing and engineering functions to ensure:

  • A robust, traceable, and compliant transformation of design intent into a validated and reliable product
  • Controlled implementation of changes
  • Long-term compliance throughout the product lifecycle

Key benefits for partners

  • 417_Infeed_vials

    Quality systems aligned with medical device and combination product regulations

  • 341_Material Characterization

    Integrated regulatory and manufacturing support

  • 273A_Modular

    Inspection-ready processes with strong documentation control

  • 162_Software simulator

    Reduced compliance risk from development through commercialization

  • 76_World-Global

    Long-term quality and regulatory partnership

Other Contract Manufacturing Services

Design & Development

Manufacturing Capabilities

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Interested in Quality and Regulatory Support?

Submit your request