Medical Device Validation Consulting
Regulatory agencies such as the US FDA have long established validation as a core requirement of quality assurance for medical device manufacturers. Still, many companies fail to develop an adequate validation program which can prove to be costly if discovered by an inspector. Over the last several years, inadequate validation has been one of the most common sources of US FDA 483 findings, so it is critical to address this requirement early. Responding to a Form 483 from the US FDA is disruptive and expensive, but can be much more so if major changes are required to retroactively validate a process, system, piece of equipment, or working environment.
Validation is broadly applied across the organization to ensure that products, equipment, processes, software and systems operate as designed and intended. Successful validation practices bring 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. Critical processes that must be validated include material handling, assembly, chemical or biological processing, purification, testing, cleaning, packaging, labeling, storage and distribution.
Emergo Group is experienced in the 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 risk for potential harm and likelihood of occurrence in order to focus testing around the functions that are the most critical. To properly evaluate these risks, our staff is comprised of 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.
Emergo Group can provide validation consulting for:
- Design validation and design transfer for manufacturing.
- Equipment commissioning and qualification.
- Facility and utility qualification.
- Computer systems and software validation.
- Automation / control system validation.
- Cleaning validation.
- Validation of chemical processing and purification processes.
- Medical device manufacturing validation.
- Validation training.
- Laboratory equipment qualification.
- Part 11 gap assessments.
Please contact us for more information or a free proposal on validation consulting for medical device companies.
