HaA PD Medical Device Testing Services
HaA Product Development provides comprehensive medical device testing services to ensure regulatory compliance, safety, and performance across Class I, II, and III devices. Our ISO 13485-certified testing facilities and experienced engineering teams offer verification and validation services that meet the requirements of the FDA QSR 21 CFR 820 regulation.
Our team boasts over 30 years of expertise in medical device testing and has successfully designed numerous medical solutions for the medical device industry. HaA PD provides end-to-end testing solutions from initial prototypes through production validation. Our integrity testing services support regulatory submissions, including 510(k) applications and Premarket Approval (PMA) submissions.
Design Verification, Validation, and Performance Testing
Design testing confirms that medical device development meets specific regulatory standards through consistent performance evaluations. We test working models and breadboard refinements to verify the feasibility of the concept. We then test prototypes to make sure that our medical devices perform according to design requirements and product specifications.
Pre-production build testing verifies manufacturing processes and identifies potential issues before full-scale production. Our testing protocols include mechanical performance, electrical safety, software validation, and system integration testing.
Usability Testing & Human Factors Validation
Human Factors Engineering Testing
At HaA PD, our human factors testing ensures safe and effective device use. We conduct cognitive walkthroughs and task analysis to find potential usability errors and optimize user interfaces. Heuristic analysis assesses devices against established usability principles for medical devices.
Formative evaluations provide iterative information during development, while summative assessments validate final designs for submission to the FDA. Use-related risk analysis identifies hazards associated with the use of a device. We compile comprehensive HF/UE reports for FDA submissions and maintain detailed human factors files throughout the development process.
User Experience Testing
Usability testing includes contextual interviews, in-person observation, and user research with healthcare professionals. Focus groups and co-creation sessions provide insights into clinical workflows and user preferences. Voice of customer interviews and key opinion leader feedback verify our design decisions and testing priorities.
We develop detailed user profiles and groups to ensure the testing represents clinical end users. We also analyze procedure steps to find use errors during our multiple test scenarios. User testing confirms that interfaces, workflows, and instructions can be used across different user populations.
Regulatory Testing & Compliance Validation
FDA Submission Testing
Regulatory testing supports premarket distribution, including safety demonstrations and predicate comparisons. We carry comprehensive testing for 510(k) submissions to demonstrate substantial equivalence to predicate devices. PMA submission testing includes clinical endpoint validation and safety evaluations.
Our testing documentation meets FDA expectations for technical sections and regulatory submissions, and our regulatory submission planning matches testing protocols with FDA requirements.
Environmental & Durability Testing
Physical & Mechanical Testing
Mechanical testing evaluates the durability of the medical device under simulated clinical conditions, including fatigue testing, strength evaluation, and wear resistance analysis. We conduct tests such as drop testing, vibration testing, and transportation simulation to assess how the device responds and handles various situations. We also conduct accelerated aging studies and stability testing to predict long-term performance and shelf life.
Environmental testing checks for humidity exposure, chemical characterization, biocompatibility testing, container closure integrity, altitude testing, and salt spray exposure. IP rating validation confirms ingress protection levels for fluids and particulate matter. Packaging integrity tests the sterile barrier throughout shelf life.
Electrical Safety & EMC Testing
Electrical safety testing checks for leaks, insulation resistance, and verification of the protective earth.
Manufacturing Process Testing, Validation, and Quality Control
Manufacturing process testing confirms the product's consistency and verifies all quality controls. We conduct installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for manufacturing equipment, each a critical component of our medical device development services.
Our design for manufacturing (DFM) testing optimizes production processes to identify the most cost-effective and efficient production method. We test for assembly procedures, quality control checkpoints, and inspection protocols.
Clinical Testing & Post-Market Surveillance
Clinical Evaluation & Testing
Clinical testing supports regulatory submissions and post-market surveillance requirements. We design clinical protocols, select the right endpoints, and coordinate clinical site activities. Clinical data analysis demonstrates safety and efficacy for regulatory submissions.
Post-Market Surveillance Testing
Post-market surveillance testing monitors the performance of our medical devices and identifies potential safety issues that may arise. Through field testing and real-world evidence, we demonstrate the importance of ongoing safety monitoring.
Why Choose HaA for Medical Device Testing
Comprehensive Testing Capabilities
Our integrated testing approach eliminates the coordination challenges that arise from working with multiple test providers. We test our medical devices from inception through to manufacturing, and our ISO 13485 certification ensures we will deliver the quality expected from medical devices.
HaA PD has developed hundreds of medical devices for various businesses, demonstrating that our products have undergone rigorous testing and are highly efficient.
Our experts have the knowledge and expertise in regulatory requirements and industry best practices. We provide complete testing documentation packages to support our regulatory submissions and quality system requirements.
Our packaging testing services scale from prototype validation through high-volume production testing.
Competitive Advantages
With HaA PD, you have a single-source testing provider, reducing complexity and timeline risks. Our manufacturing mindset gears our testing toward production efficiency. Thanks to our cross-industry experience, we bring innovative testing approaches to the medical device industry.
Because we test our medical devices from inception, we can spot an issue before costly design changes, saving our clients time and money.
Finally, we continually monitor the evolution of our industry, and our testing protocols are regularly updated to meet changing regulatory requirements and global industry standards.
HaA PD for Your Medical Device
If you want to develop a medical device and need efficient and accurate comprehensive testing services, HaA PD is the best partner to guide you through the product's life cycle. Our experienced testing teams provide the expertise, facilities, and laboratories to assess your medical device safely and efficiently.
Contact HaA PD today or schedule a free strategic consultation to learn how we can help bring your vision to life!