Services
Consulting
We can help with all aspects of safety compliance and be your go to expert for issues that may arise.
Field Evaluations
We can provide field labeling and evaluation services to secure approval from local inspectors and quickly get your products in compliance.
Semi S2
Consider us to help with your equipment evaluations.
IEC 60601-1
We offer full 60601-1 testing and consulting services as well as tailored testing of your product when you need to evaluate early on in the product development process.
IEC 61010-1 Testing
We offer 1010 testing services for Measurement control and Laboratory equipment. Call or email for a quote!
EMC Partnership Testing
We partner with local EMC labs to provide you with a comprehensive "one-stop shop" for all your testing and certification needs.
510K submission, MDR and Regulatory Guidance
We will guide you through the 510(k) submission process and the MDR regulatory guidance reporting with speed and efficiency in order to keep time and cost to market at a minimum. We have extensive experience working directly with the FDA and its reviewers, and can provide you with in-depth product knowledge and industry expertise throughout your submission review.
EU Machinery & Low Voltage Directives
With our expert guidance we provide compliance services for machinery directive 2006/42/EC, which also contains requirements for risk analysis where we can assure you that your product will receive the highest level of evaluation and the safest design.