Medical Device Manufacturer

Medical Device Validation

Tailored solutions to help manage your global regulatory requirements and quality assurance

ISO 13485:2003 is a quality system standard designed specifically for medical device companies. The ISO 13485 standard has many of the same requirements as ISO 9001. However, there are additional requirements for process control, design control, retention of records, accountability, traceability and more.

Process validation is an essential part of medical device manufacturing

Operating to ISO 13485:2003 means Riverside Medical Packaging meet the quality system requirements in Europe, Canada, Japan, Australia and many other countries. Design, installation, operational and performance qualification ensure complete and seamless validation.

Validation ensures all devices and processes are reliable, repeatable and fit for purpose

  • Creation of Validation Protocols covering all aspects of:

        - Design Qualification
        - Component DFM, Mould tool design, URS, Risk Assessment, FAT
        - Installation Qualification
        - R & R, MSA, SAT, Equipment Environment Facility
        - Operational Qualification
        - Process optimisation, Process capability analysis, Functional & dimensional assessment
        - Performance Qualification
        - In-process testing, Product training, Batch traceability, Production control
        - Final Summary Report
        - IQ/OQ/PQ Checklists, FAT & SAT Reports, FOIRs/ISIRs, MSA/R & R Studies,

        - Capability Studies, Interchangeability Studies

  • Full validation of mould tools, processes and equipment

100-percent inspections to get 100% consistency

Medical Device validation ensures that the products manufactured consistently meet the applicable requirements and specifications. Validation of processes used to sterilise drug products and equipment are the most critical validation activities undertaken. The objective of Validation is to determine that the sterilisation process will consistently achieve sterility and that it won't have an undesirable effect on the device or its packaging.

Find out more about how Riverside Medical Packaging can help you with your medical device manufacture call 0845 618 1941 or complete the enquiry form