Welcome to Device Conformity and Testing
Located in Devens, MA, and operating since 2018, Device Conformity and Testing, LLC is an A2LA ISO 17025:2017 accredited electrical safety test lab.
We specialize in:
- Medical device consulting and testing to IEC 60601-1
- IEC 61010-1 testing
- SEMI S2 evaluations
- EU Machinery and Low Voltage directives support
At DC&T we are uniquely positioned to support multiple customized testing needs and regulatory functions. We partner with EMC Labs in the area for testing support as well as offer regulatory consulting for FDA 510K and MDR project work as part of our quality division.
Our engineers and contributing consultants have years of NRTL experience, in field evaluation work, laboratory test and measurement equipment, information technology and industrial control products. We have been independently supporting clients throughout the U.S. for over 30 years.
Our goal is to continue to expand our lab capabilities, to further the tradition of extraordinary service, flexibility and understanding of our customer needs while supporting projects from conceptual design to legacy products.
978-697-4665
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.