The Applied Technical Services Family of Companies (ATS FoC) performs medical device validation testing to help manufacturers evaluate whether a device, process, or supporting system meets its intended requirements. Validation activities provide objective evidence that defined requirements are consistently addressed under specified conditions. These activities support quality planning, product development, manufacturing, and regulatory documentation.
ATS provides professional testing and engineering services for clients operating in medical device development and manufacturing. Our technical teams apply established testing methods and documented procedures in our ISO/IEC 17025:2017-accredited, ISO 9001:2015-registered testing laboratories to support validation programs. Testing can be tailored to the device, process, intended use, and applicable project requirements.
What Does Medical Device Validation Testing Include?
Medical device validation testing evaluates whether a medical device or related process can consistently achieve its intended results. The scope depends on the product and the processes used to develop or manufacture it. Validation testing involve areas such as:
- Product performance and functional testing
- Manufacturing process validation
- Packaging and sealing validation
- Sterilization-related validation support
- Software and automated system validation
- Equipment and process qualification
- Environmental and durability testing
- Materials and component evaluation
- Performance testing under defined conditions
The appropriate testing program depends on the device and its intended application. Validation requirements also vary based on the manufacturing process, device characteristics, and applicable regulations or standards.
How Does Medical Device Validation Testing Support FDA Compliance?
The FDA’s current Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 by reference and became effective February 2, 2026. The framework emphasizes risk-based quality management and controls throughout medical device development and production. Medical device validation testing benefits organizations at several stages of the product lifecycle. Typical users include:
- Medical device manufacturers
- Pharmaceutical and combination-product manufacturers
- Contract manufacturers
- Medical technology companies
- Product development organizations
- Original equipment manufacturers (OEMs)
- Manufacturers introducing new production processes
- Companies modifying existing manufacturing methods
Validation testing may also become relevant when a company changes equipment, materials, software, production methods, or other controlled processes.
Why Medical Device Validation Testing Matters
Validation provides documented evidence that a defined process or system is capable of achieving its intended results. This information helps organizations identify performance concerns before they affect production or product quality.
Effective validation also supports risk management and quality decisions. Testing may reveal variability, limitations, or conditions that require further evaluation. Addressing these findings early helps organizations make informed engineering and quality decisions.
Process validation is particularly important when subsequent inspection or testing cannot fully verify the resulting output. FDA guidance describes process validation as establishing objective evidence that a process can consistently produce results meeting predetermined specifications.
Medical Device Validation Testing at ATS
ATS approaches medical device validation testing with an emphasis on technical accuracy, documented procedures, and clear reporting. Our engineers and technicians work with clients to define testing objectives and develop an appropriate evaluation approach.
Testing programs may incorporate applicable industry standards, customer specifications, regulatory considerations, and project-specific requirements. The selected methods should reflect the characteristics and intended use of the device or process.
ATS supports validation efforts by providing technical testing and engineering expertise throughout the project. We focus on delivering test data and documentation that organizations can use in their quality and validation processes.
Medical device validation testing is essential for demonstrating consistent performance and maintaining controlled manufacturing practices. Partnering with the trusted experts at ATS offers manufacturers valuable expertise specialized equipment, technical personnel, and structured testing capabilities.
Contact Us
Get in touch with the proven medical device validation testing experts at ATS today by submitting a web request form or calling +1 (888) 287-5227.
