Quality and Compliance

With manufacturing facilities in Europe, Asia and USA, the SteriPack Group has gained an in-depth of country specific requirements. SteriPack Group provides solutions that satisfy Customer-specific requirements, which are tailored to the needs of local markets and while adhering international standards.

Each manufacturing facility’s Quality Management System is certified to industry standards. All facilities are FDA.

Strict Quality Management System ensures consistent delivery and instils confidence in Customers. SteriPack consistently delivers a services that meet Customers’ needs and regulatory requirements by applying and managing stringent Quality Management System.

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

  •  Control of Documents and Records documentation support
  •  Specification controls to include Customer requests
  •  Monitoring of on-going quality trend analysis
  •  Active internal auditing programme
  •  Established corrective and preventative action (CAPA) system
  • ISO 13485:2016 compliant to MDD 93/42/EEC, Annex II
  • ISO 13485:2016 under MDSAP
  •  FDA registered
  • Health Canada registered
  •  Pharmaceutical Manufacturing Authorisation for primary and secondary packaging (cGMP)
  •  Pharma and Medical Device Act (PMDA) November 25, 2014/JPAL
  •  PN-EN ISO/IEC 17025:2018 Accredited Laboratory
  •  ISO Class 7 and 8 clean rooms
  •  Grade D pharmaceutical clean room
  •  Temperature and humidity controlled manufacturing environment
  •  CE marked and 510(k) cleared devices

Our certificates:

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

UDI compliance

SteriPack Group offers packaging labelling compliant with the global UDI regulations for medical devices. 

UDI benefits include:

  •  Identification and traceability of medical devices
  •  Adequate identification of medical devices throughout device life cycle

SteriPack's expertise:

medical devices and pharmaceutical products compliance with quality regulations.

Quality and microbiological testing

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