Regulatory Support

Validation Processes in Manufacturing, Stability and Sterilization

With more than 50 years in developing, manufacturing, and distributing Class I and Class II medical devices worldwide, we have the know-how and experience in producing products that comply with FDA regulations.

We offer expertise in creating technical files, 510k, validation, and CE marking of your products.

Manufacturing Process Validation

  • Assembly
  • Packaging
  • Device or Product

Stability Validation

  • Distribution
  • Package and Device Integrity
  • Accelerated Aging
  • Real Time Aging

Sterilization Validation

  • ISO 13485 - Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry
  • FDA 21CFR 820 compliant
  • ISO 11607 – Packaging for Terminally Sterilized Medical Devices
  • F 1980 – Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
  • ISTA 3A:2008 – Packaged-products For Parcel Delivery System Shipment
  • ASTM D4169-09 – Standard Practice for Performance Testing of Shipping Containers and System
  • AAMI ISO 11135-1 – Sterilization of healthcare products - Ethylene Oxide: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices

Applicable Standards

  • ISO 13485 - Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry
  • FDA 21CFR 820 compliant
  • ISO 11607 – Packaging for Terminally Sterilized Medical Devices
  • F 1980 – Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
  • ISTA 3A:2008 – Packaged-products For Parcel Delivery System Shipment
  • ASTM D4169-09 – Standard Practice for Performance Testing of Shipping Containers and System
  • AAMI ISO 11135-1 – Sterilization of healthcare products - Ethylene Oxide: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices