Medical device – Validation

The requirements to validation and the related documentation of process and IT and software validation in the Medical Device industry are elevation currently through updated regulations from the authorities. AL Engineering have many years of experience within process and IT and software validation within the Medical Device industry in Denmark and foreign countries

AL Engineering can therefore assist your company defining the right strategy for validation and secure that the validations are carried out as intended according to requirements. This is for large and complex equipment/ facilities, new equipment or revalidation of existing equipment.

The AL Engineering Medical Device business offers amongst others customized templates for validation based on the best practices in the industry.

We can manage and conduct validation activities according to your quality system (QMS) and your specific requirements. This is documentation as

  • RA – Risk assessment
  • VPL – Validation plan
  • URS – User Requirement Specification
  • DS – Design Specification
  • FAT/SAT – Facility Acceptance Test/ Site Acceptance Test
  • RTM – Requirement Traceability Matrix
  • Protocols/ test plans and reports for
    • DQ – Design Qualification
    • IQ – Installation Qualification
    • OQ – Operational Qualification
    • PQ – Performance Qualification
    • PPQ – Product Performance Qualification
  • Test protocols, test references and test plans
  • Non-conformities and change control
  • Other relevant documentation, QMS and compliance documentation

Contact

Please contact Medical Device, Area Manager Lars Grønborg for a non-committal talk about how we can make a difference for your company.

+45 2446 6353