Medical Devices
Having Compliance Issues?
Are you frustrated working directly with the NRTLs? Do you know 60601 requirements? We have Medical Subject Matter Experts on staff that can make sense of it all. Give us a call or contact us via the website.
SETTING THE STANDARD IN
Medical Device Testing
Product Safety Consulting (PSC) is your trusted partner in establishing a culture of safety throughout your product’s lifecycle. Our approach has been embraced by some of the world’s largest companies, who turn to us for expert guidance on product safety and compliance. We go beyond conventional testing by providing clear explanations of safety issues that often surface during the testing process. At PSC, our commitment is not only to identify non-compliance but to offer effective solutions, ensuring that your product meets the highest safety standards.
In our eyes, success is defined by your product’s approval and successful launch, followed by a lasting and productive business relationship. We are proud to highlight that a significant portion of our work, approximately 70%, comes from repeat customers deeply engaged in product development. This statistic underscores the quality of our work and the trust our clients place in our expertise. At Product Safety Consulting, we believe our services reflect our dedication to excellence.
Key Points in which we can help:
- Our expertise in medical device testing encompasses a wide array of essential aspects, including:
- Risk Management File: Creating a comprehensive Risk Management File that includes a Hazard analysis and Risk Assessment as expected by Notified Bodies and required by the Medical Device Directive and the In Vitro Device Directive and the FDA.
- Device Classification: Determining the appropriate classification for your device, whether it falls under Class I, II, or III, or if it is better suited as a wellness product.
- Upclassification: Identifying whether your device has been upclassed to a different category.
- FDA 510K: Assessing the need for an FDA 510K submission.
- Test Plan Development: Crafting a test plan that includes specific pass/fail criteria aligned with your device’s intended purpose and Essential Performance, which is necessary for all conformance testing.
- Standard Identification: Identifying the proper consensus and harmonized standards applicable to your device.
Services – We have the experience
- Our comprehensive range of services includes:
- Designing for Safety Approvals (DFSA™): Our DFSA™ initiative encourages early involvement to integrate safety requirements into your product’s design.
- Design Reviews: In-depth reviews to ensure safety considerations are embedded in the design.
- Construction Evaluation: A thorough examination of the product’s construction to verify compliance.
- Testing: On-site or in our state-of-the-art laboratory, we offer reliable and comprehensive testing.
- Submittal Management: We take care of the intricate process of managing submissions, ensuring compliance with regulatory requirements.
- Technical Documentation: Evaluation and creation of necessary technical documentation.
- Gap Analysis: We conduct comprehensive gap analyses to ensure compliance with regulations and testing requirements.
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.
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 Device 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.
Safety Beyond Standards – Our Philosophy
At Product Safety Consulting Inc., we do not settle for merely meeting minimum safety requirements. Our philosophy, Safety Beyond Standards (SBS™), drives us to take safety to the next level. We work closely with you to Design for Safety Approvals, offering solutions to non-compliance rather than simply delivering pass/fail statements. We pride ourselves on providing clear and straightforward explanations of safety issues that often surface during the testing process.
We are known for our speed, efficiency, and accuracy. Our team complements and enhances your internal experts, ensuring that testing is conducted precisely to your requirements. We excel in guiding your team through the intricate submittal and certification process.
Contact us today for a No-Cost Consultation at 877.804.3066. Let Product Safety Consulting Inc. be your trusted partner in achieving the highest standards in medical device safety and compliance. We are committed to your success throughout your medical device’s development and certification journey.
Ready to
Get Started?
Contact us today and let us embark on the journey to product safety and compliance together.