Medical Device Manufacturing Process Validation

  • Home
  • Medical Device Manufacturing Process Validation

Validation is broadly applied across the organization to ensure that products, equipment, processes, software, and systems operate as designed and intended. A successful validation program brings together engineering, manufacturing, regulatory compliance, and quality assurance to develop test solutions that are unique to each application. Developers of medical devices must validate the product design to ensure that it meets the user's requirements. Manufacturers of medical devices must validate any process, including any associated equipment and software, whose entire output is not or cannot be fully verified by inspection. Examples of these types of processes are sterilization, packaging systems, soldering processes, and automated systems. Critical processes that may require validation include material handling, assembly, chemical or biological processing, purification, testing, cleaning, packaging, labeling, storage, and distribution.

Intellectt is experienced in validation of many types of equipment, processes, and systems used in a wide variety of medical device applications. We use a risk-based approach to validation that analyzes each process for potential harm and likelihood of occurrence in order to focus testing around the most critical functions. To properly evaluate these risks, our staff includes engineers and scientists who understand the technical functionality of the process. We work closely with each client to tailor validation projects to their exact needs.

  • Drug Manufacturing (Oral/liquid dosage) Process Validation
  • Test Method Validation
  • Cleaning Validation
  • Supplier Quality Validation
  • Electrical System Validation
  • Utilities/HVAC Validation
  • Computer System Validation (CSV)
  • CAPA Owners/ Investigators
  • Quality Assurance
  • Thermal Validation
  • Packaging Validation
  • Passivation process Validation
  • Sterilization process Validation