Quality Management Systems
- ISO 9001:2015 certified for design, prototyping, and testing of RF systems
- ISO 13485 aligned processes for medical device engagements
- ITAR compliant infrastructure for defense programs, including secure data handling and facility controls
Every project inherits structured documentation templates, change control boards, and audit trails. Clients gain portal access to requirements traceability, risk registers, and lab reports in real time.
Regulatory Expertise
Wireless Standards
We manage FCC Part 15, Part 25, ETSI EN 300 328/422, RED directives, MIC/TELEC approvals, and Industry Canada submissions with repeatable workflows.
Aerospace & Defense
DO-160, MIL-STD-461, and NASA-STD-4009 requirements are built into requirements plans, with pre-conditioning to derisk official lab tests.
Medical Devices
IEC 60601-1-2, IEC 61000-4-x, and FDA guidance documents inform test matrices and usability validation plans for connected health products.
Automotive
ISO 11452, CISPR 25, and UNECE regulations are addressed alongside functional safety reviews and cybersecurity assessments.
Compliance Workflow
- Requirements Mapping: Align standards, jurisdictions, and documentation expectations with program goals.
- Design Reviews: Evaluate architecture decisions for emissions, immunity, and coexistence implications.
- Pre-Compliance Testing: Execute emissions, susceptibility, and OTA scans in our lab to uncover risks early.
- Accredited Lab Campaign: Coordinate scheduling, witness tests, and manage corrective actions where necessary.
- Technical Construction File: Deliver audit-ready packages including schematics, BOMs, firmware, and declarations of conformity.
Lab Accreditations and Partners
Our internal lab operates under ISO/IEC 17025 principles and partners with accredited facilities across North America, Europe, and Asia-Pacific. We maintain long-standing relationships with SGS, TÜV SÜD, UL Solutions, and regional specialists to secure test slots even during high-demand cycles.
Need to evaluate your program’s compliance strategy? Contact our compliance team or download templates from the resource center.