Compliance is necessary to assure medical devices are safe and meet specified requirements and guidances. Full Spectrum supports your compliance needs while providing practical, value-add approaches to compliance.
Relevant Standards Alignment & Compliance
We help your team navigate testing at the NRTL, developing appropriate test plans and completing necessary compliance checklists early enough in the development process to achieve certification.
IEC 60601, Essential Performance & EMC Application
We help analyze your product, identifing essential performance and developing specific test plans to be used by NRTL's in safety and EMC testing.
Design File Assessment & Management
We help your team understand what documentation is appropriate, compliant and value-add, ensuring support for product changes throughout the lifecycle.
FDA Submission Technical Content Development
With our extensive experience supporting product submissions to the FDA, we help your regulatory team assemble or create the appropriate technical documentation necessary to assure product clearance.
Quality System Process & SOP Compliance
We work with your team to optimize value-add processes, develop quality systems and SOPs, and identify and implement process tools.