Product Safety Consulting guides you through the process of obtaining safety certification in the fastest time and for the least cost. We have years of experience testing products according to FDA 501K, UL/IEC 60601 and 61010. We help you not only verify the classification of your medical device, but get you through the conformity assessment process – from designing for compliance, to applicable essential requirements, to testing your product, to achieving certification.
- UL/IEC 60601 3rd Edition requires a Risk Management File
- Most countries now require 3rd Edition
- How is it classified? Class I, II or III
- Is FDA 510K needed?
- Quality Management is required – ISO 13485
Services – We have the experience:
- Designing for Safety Approvals – DFSA™ – Get us involved early and we help build the requirements into the design
- Design Reviews
- Construction Evaluation
- Testing – on site or in our laboratory
- Submittal Management
Our laboratory is fully audited to ISO 17025. We can test at our facilities under programs for data acceptance with UL, IEC, and QPS. This means we can conduct testing on your schedule. For devices already installed, or on trial, we can perform field inspections and evaluations in any North American hospital, clinic, or lab.
We can also help you with European Standards (CE):
- Verification of classification
- Determination if a Notified Body is required
- Assist in preparing your CE Technical file
- Assist in risk analysis
Safety Beyond Standards is our philosophy – it’s how we think and how we help you design your products. We recognize that product safety standards too often represent the minimum requirements. At PSC, we help you Design for Safety Approvals. We offer solutions to non-compliance rather than simply reporting a pass/no-pass statement. And, we communicate with straightforward explanations of safety issues that often arise during the testing process.
We are fast, efficient and accurate. Our team compliments and enhances your internal experts. We can get the testing done at our lab or at your site, as required.