We work as an integral part of your product engineering team to help ensure that your product will meet all applicable standards and regulatory requirements, including EMC, from the early stages of design and throughout the product’s life cycle. We also act as your agent, representative and sample concierge when dealing with compliance test laboratories, safety authorities, and regulatory bodies.
Starting from a high-level product compliance and regulatory roadmap, we plan and execute each stage to make the product realization process run as smoothly and cost-effectively as possible.
This also includes facilitating all applicable requirements of the formal design process:
REQUIREMENTS IDENTIFICATION (or review for gap analysis with existing products)
- Identify intended use of product
- Identify applicable regulatory jurisdictions (based upon client’s distribution targets)
- Identify product’s classification
- Identify RA submission requirements
- Identify applicable standards
- Identify safety agency certification requirements
- Identify process requirements for risk management, usability, and software life-cycle
INITIAL DOCUMENTATION REVIEW
- Review product’s design file or design plan (i.e. engineering requirements, system architecture, software and firmware specifications, accessories, interconnections, power source) and determine project scope
- Review client’s risk management procedures against requirements
- Review product’s risk management file
- Review product’s instruction manual and markings against requirements
- Review software documentation, as applicable
- Review usability engineering documentation, as applicable
- Work with client to resolve any documentation, markings, and process deficiencies
INITIAL PRODUCT CONFORMITY ASSESSMENT
- Evaluate product’s construction against applicable standards
- Review operating instructions and device markings for test applicability
- Generate isolation diagram to document electrical means of protection
- Identify and review critical components for conformity requirements
- Review risk management, software and usability engineering files for test applicability
- Identify applicable tests
- Manage preliminary safety & EMC testing as part of client’s engineering design verification (optional upon request)
- Issue initial evaluation & preliminary test reports for client’s in-house verification needs (optional upon request)
- Issue risk management tables, as applicable to standard (optional upon request)
- Work with client to resolve any initial nonconformities, test failures, and process deficiencies
FORMAL COMPLIANCE TESTING (conducted by an accredited test laboratory after initial non-conformities have been resolved)
- [in-SPEX] Define safety mark and report requirements, as required by the project scope and the client’s regulatory approval objectives
- [in-SPEX] outsource testing to a test laboratory with the appropriate accreditations (i.e. NRTL, CB Scheme, etc)
- [in-SPEX] Assist client with initiating service agreements with test lab, as required
- [Test Lab] Obtain production-equivalent samples with documentation and verify operation
- [Test Lab] Document product’s construction and means of protection
- [Test Lab] Photograph product showing its dimensions and safety-critical construction feature
- [Test Lab] Test according to the base standard, as well as applicable collateral and particular standards and national differences
- [Test Lab] Report back on test results and inform client of any test failures or residual product non-conformities
- [in-SPEX] Assist client to resolve testing & non-conformity issues reported by test lab
- [Test Lab] Conduct retesting, as appropriate
- [Test Lab] Issue test data report or test results summary
FORMAL COMPLIANCE REPORTING (test laboratory writes compliance report covering general standard, collateral standards, particular standards, national differences, using applicable IECEE checklists)
- [in-SPEX] Liaise between client and test laboratory to address test lab’s issues or additional information requirements
- [Test Lab] Fill-in prduct description and insulation diagram
- [Test Lab] Fill-in checklist verdicts
- [Test Lab] Fill-in test data tables and risk management tables (where appropriate)
- [Test Lab] Fill-in table of critical components
- [Test Lab] Prepare and attach supporting documents to report: photographs, instructions for use, illustrations including applicable drawings and schematics
- [Test Lab] Conduct a technical review, address any review findings, and issue compliance report along with authorization to apply their safety mark and/or a CB Report and CB Certificate (as defined by the outsourced project scope)
FINAL STEPS
- [in-SPEX] Advises client on next steps towards obtaining regulatory approvals (see Global Market Access Support tab) and assists with accommodating the test lab’s NRTL follow-up inspection requirements