Contract Manufacturing Services

Quality and Regulatory Support for Medical Devices

Quality systems aligned with medical device and combination product regulations
Integrated regulatory and manufacturing support
Inspection-ready processes with strong documentation control
Reduced compliance risk from development through commercialization
Long-term quality and regulatory partnership

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 environments operate within inspected and audit-ready sites.

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:

Alignment of manufacturing and quality documentation with regulatory requirements
Support for design transfer and industrialization readiness
Contribution to regulatory submissions and technical documentation, where applicable
Support for biocompatibility studies, shipping validation, and stability testing
Ongoing support for post-market changes and lifecycle management

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

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