Quality and Compliance

With manufacturing facilities in Europe, Asia and USA, the SteriPack Group has gained an in-depth understanding of country specific requirements. This means the SteriPack Group can guarantee solutions that satisfy Customer-specific requirements, are tailored to the needs of local markets and adhere to international standards.

Each facility delivers medical device quality assurance and management, is appropriately certified to industry standards and have been FDA registered to produce medical devices for the pharmaceutical and medical device markets.

Strict quality management ensures consistent delivery and instils confidence in Customers. SteriPack consistently delivers a service that meets the needs, both of Customers and statutory requirements by applying a strict and thorough quality management system. Additionally, procedures are regularly critiqued through internal notified bodies and Customer audits to ensure the highest standards are maintained.

Established medical device quality assurance and management procedures at the SteriPack Group:

  •  Complete documentation support
  •  Specification controls to include Customer requests
  •  Monitoring of on-going quality and trend analysis
  •  Active internal auditing programme
  •  Established corrective and preventative action (CAPA) system
  •  ISO 13485:2016 compliant to MDD 93/42/EEC, Annex II
  •  FDA registered and audited 21 PART 820 Quality System Regulation compliant
  •  Pharmaceutical Manufacturing Authorisation for primary and secondary packaging (cGMP)
  •  ISO 13485:2016 under MDSAP
  •  Pharma and Medical Device Act (PDMA) on November 25, 2014/JPAL
  •  PN-EN ISO/IEC 17025:2018 Accredited Laboratory
  •  Compliant with 21 CFR 210/211/4 (US)
  •  Compliant with SOR 92/282 (Canada)
  •  ISO Class 7 and 8 clean room production
  •  Grade D pharmaceutical clean room production
  •  Temperature and humidity controlled manufacturing environment
  •  CE marking
  •  510K submission
  •  Canadian registration

Our certificates:

  •  EN ISO 13485:2016 Certificate
  •  ISO 13485:2016 under MDSAP
  •  PN-EN ISO/IEC 17025:2018 Laboratory Accreditation
  •  EC Certificate under MDD
  •  GMP Certificate
  •  ISO 22716:2007 Certificate for Cosmetics

UDI compliance

The SteriPack Group offers packaging services compliant with the global UDI regulations for medical devices. The medical devices label and/or the packaging have the UDI information. The UDI produced for a device comprises a UDI-DI (device identifier – specific to a manufacturer and device) and a UDI-PI (production identifier – identifies unit of device production). The composition of the UDI is common with the FDA UDI implementation and IMDRF description. All the UDI concerned data follow the globally used formats.

A globally consistent approach to the medical devices identification represented through the UDI system is designed to increase patient safety and help optimise patient care by facilitating:

  •  Traceability of medical devices, especially for field safety corrective actions
  •  Adequate identification of medical devices through distribution and use
  •  Identification of medical devices in adverse events
  •  Reduction of medical errors
  •  Documenting and longitudinal capture of data on medical devices

SteriPack's expertise:

medical devices and pharmaceutical products compliance with quality regulations.

Quality and microbiological testing

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