Medical & Lab Equipment Testing

SETTING THE STANDARD IN

Medical & Lab Equipment Testing

Product Safety Consulting Inc. is your dedicated partner in guiding you through the intricate process of obtaining safety certification for Medical and Laboratory Equipment in the most expedient and cost-effective manner. With years of experience testing products according to FDA 510K recognized standards, UL/IEC 60601 and 61010, we provide comprehensive support to help you navigate the journey from product design to certification. We understand the critical steps necessary to not only verify the classification of your Medical and Laboratory Equipment but to successfully navigate the conformity assessment process. From designing your device for compliance to meeting essential requirements, testing your product, and ultimately achieving certification, we are by your side every step of the way.

Safety Testing

Our state-of-the-art laboratory operates under ISO 17025 protocols, ensuring the highest standards in safety testing. We offer flexibility in testing, whether at our facility or under the NRTL’s witness testing program. This means that we can tailor testing to your schedule.

We are also in Nemko’s Data Acceptance Program – Nemko accepts our test data so once you’re in compliance, Certification is only 1-3 weeks away.

For devices already installed or on trial, we provide field inspections and evaluations in any North American hospital, clinic, or lab. Additionally, for submittal purposes, we can supply detailed test reports and documentation for presentation to the FDA and other regulatory bodies.

We are also well-versed in European Standards (CE), UKCA, and NI for Medical and Laboratory Equipment Regulation and In Vitro Device Regulation.

Our services include:

• Verification of Classification: Confirming the correct classification for your device.
• Notified Body Assessment: Determining if a Notified Body’s involvement is required.
• Technical Documentation: Both creating and reviewing essential technical documentation.
• Hazard Analysis and Risk Assessments: In-depth assessments to ensure product safety.
• Development of Test Plans and Test Reports: Crafting comprehensive test plans and reports to demonstrate compliance.

Starting from concept, we help you make it pass first time through a Certification process:

• Designing for Safety Approvals (DFSA™): Our DFSA™ initiative encourages early involvement to integrate safety requirements into the design of your appliances.
• Design Reviews: We conduct in-depth design reviews to ensure safety considerations are an integral part of the appliance’s blueprint.
• Construction Evaluation: A thorough examination of the appliance’s construction to verify compliance with safety standards.
• Testing: We offer comprehensive testing services, whether on-site or in our state-of-the-art laboratory.
• Submittal Management: We take on the complex task of managing submissions, ensuring that all regulatory requirements are met.
• Data Acceptance Program – Nemko accepts our test data so once you’re in compliance, Certification is only 1-3 weeks away.