CERTIFIED FIRSTATTEMPT,EVERY TIME.
We engineer compliance in—not tested in at the lab.
Certification failures cost $20,000–$60,000 per re-test cycle and delay launches by 2–4 months. Ankh integrates compliance into design from schematic review through PCB layout and firmware, so lab submissions reflect pre-validated designs. We manage the full lifecycle—standard selection, pre-compliance testing, technical file preparation, and post-certification maintenance—across FCC, CE, UKCA, UL, IC, BT SIG, Wi-Fi Alliance, Matter/Thread, and medical device frameworks.
What We Certify
FCC Certification (Part 15B/C, 22, 24, 90)
Ankh manages FCC certification across Part 15B/C (Wi-Fi, BLE, Zigbee), Part 22/24 (cellular PCS), and Part 90 (private land mobile) — including SDoC vs. TCB grant strategy, RF test report preparation, SAR coordination, FCC ID labeling, and post-approval change filings.
CE Marking (RED, EMC, LVD, RoHS, REACH)
CE marking under RED 2014/53/EU, EMC Directive 2014/30/EU, and LVD 2014/35/EU — technical file preparation, EU DoC drafting, notified body engagement for Article 17 assessments, and RoHS 2/REACH SVHC documentation.
BT SIG, Wi-Fi Alliance & Matter/Thread Certification
BT SIG QDID listing, Wi-Fi Alliance WFA certification (Wi-Fi 4/5/6/6E, WPA3, EasyConnect), Matter CSA PICS/PIXIT preparation and test harness execution, and Thread Group certification — with component QDID re-use to reduce qualification scope.
Medical Device Regulatory (IEC 60601, ISO 13485, FDA)
Ankh prepares FDA 510(k) files with substantial equivalence analysis and SaMD documentation; manages IEC 60601-1 3rd edition NRTL testing (electrical safety, 60601-1-2 EMC, 60601-1-8 alarms); and delivers ISO 13485 QMS gap assessments.
International Type Approvals (UKCA, IC, MIC, KC, CCC)
Type approvals for UK (UKCA/RER 2017), Canada (IC/ISED RSS-247), Japan (MIC/VCCI), South Korea (KC/RRA), and China (SRRC/CCC) — with parallel multi-market submission via established test house partnerships.
Pre-Compliance Testing & Test Planning
Pre-compliance radiated and conducted emissions using calibrated LISNs, biconical and log-periodic antennas, and 3-meter semi-anechoic measurements — with near-field source correlation and ESD/EFT/surge immunity testing before accredited lab scheduling.
SAR Testing & RF Exposure Compliance
SAR compliance under FCC OET Bulletin 65, IEEE 1528, IEC 62209-1528, and EN 50566 — including antenna gain characterization, conducted power measurement, separation distance analysis, and accredited SAR facility coordination.
UL, ETL & CSA Safety Certification
UL Listing, ETL Listed, and CSA certification for ITE (UL 62368-1), household appliances, and industrial equipment — standard applicability analysis, sample submission, factory inspection coordination, certificate maintenance, and UL 2900 IoT Security Rating.
How We Work
Regulatory Scoping
Target markets, radio technologies, and power supply configuration are mapped to the applicable standards in each jurisdiction, producing a certification matrix of approvals, costs, timelines, and design constraints. Scoping before layout begins ensures regulatory requirements shape design — not force redesigns after prototypes exist.
Design-Phase Compliance Integration
Compliance checkpoints are embedded into design reviews: PCB layout reviews check decoupling placement, return path continuity, and clock routing; schematic reviews verify isolation barrier creepage, ESD protection, and conducted emissions filter topology. Antenna placement, keep-out zones, and cable routing are reviewed for radiated emissions impact.
Pre-Compliance Testing
Near-field probing, LISN-based conducted sweeps, and 3-meter radiated measurements on first-prototype hardware establish compliance margins before accredited lab scheduling. Failures are diagnosed to specific source nodes and bench-retested; pre-compliance data shared in advance focuses the test house on flagged frequencies rather than full exploratory sweeps.
Technical File Preparation
CE technical files include harmonized standard lists, test reports, risk assessment, and Declaration of Conformity; FCC TCB packages include equipment description, test setup diagrams, and test data. Medical device technical files follow FDA 510(k) guidance structure or EU MDR Annex II/III as applicable.
Accredited Lab Coordination
Test house booking, sample preparation, witness attendance, and results communication are managed end-to-end. Relationships with FCC TCBs, EU notified bodies, and UL labs enable priority scheduling compressing lead times by 3–6 weeks; test failures receive rapid root-cause diagnosis to avoid full-cost retests.
Certification Maintenance
Component substitutions, firmware updates, and PCB revisions all carry re-certification exposure that can invalidate existing grants if unassessed. Every change is evaluated against FCC Class II/III and CE update thresholds; annual UL inspections and BT SIG monitoring are managed under the maintenance retainer.
Compliance Engineered In, Not Tested In
EMC Design Integration: From Layout to Accredited Chamber
EMC compliance requires management from schematic capture through layout, enclosure, and cable selection. PDN decoupling targets <10–50 mΩ across 100 kHz–500 MHz; return-path continuity rules eliminate split-plane crossings; common-mode choke and EMI filter networks are sized from measured cable impedance.
Electronics DesignMedical Device Technical File: FDA 510(k) & EU MDR
FDA 510(k) submissions require substantial equivalence evidence — performance data, IEC 62304 documentation, cybersecurity guidance compliance, and ISO 10993 biocompatibility — with complete traditional submissions including test protocols. EU MDR Class IIa/IIb notified body assessment per Annex IX/X uses an MDCG-aligned technical file from selection through certificate issuance.
Systems IntegrationModular Approval & Component Re-Use Strategy
Pre-certified radio modules reduce certification cost only when integration conditions — antenna gain, separation distances, host labeling — are strictly met. Module conditions are audited to identify whether SMOD, LMOD, or SPMD applies; BT SIG supply chain QDIDs are assessed to reduce qualification scope to the end-product host subsystem.
RF & Wireless Engineering
We engineer compliance in—not tested in at the lab.
Regulatory Certification Across Ankh's Product Range
Every product category carries a distinct regulatory burden — our certification team has direct experience across all of them.
Medical Devices
FDA 510(k) preparation, IEC 60601-1/60601-1-2 testing, ISO 13485 QMS gap assessment, and EU MDR technical file preparation
View ProductWearable Electronics
SAR testing for body-worn devices, FCC Part 15C, CE RED, BT SIG QDID listing, and IPX ingress protection certification
View ProductWireless Communication
FCC Part 22/24/90, IC RSS-247, PTCRB carrier approval, GCF certification, and ICASA (South Africa) for global cellular products
View ProductAI Vision Systems
FCC Part 15B conducted and radiated, CE RED for Wi-Fi/BLE variants, and IEC 62368-1 safety for mains-connected vision appliances
View ProductSmart Home Automation
Matter/Thread CSA certification, Wi-Fi Alliance WPA3, BT SIG listing, and UL 60730 appliance control safety for mains-switching devices
View ProductIndustrial Equipment Monitoring
IEC 61000-6-2/4 industrial immunity, ATEX/IECEx Zone 2 intrinsic safety, and UL 508A industrial control panel listing
View ProductPOS & Kiosk Hardware
PCI-PTS HSM device evaluation, EMV Level 1 (L1) type approval, UL 60950-1, and FCC/CE for integrated card reader and display
View ProductCold-Chain Monitoring
WHO PQS pre-qualification for temperature recorders, FCC/IC for NB-IoT variants, and CE RED with environmental testing per IEC 60068-2
View ProductPower Monitoring
IEC 62053/ANSI C12.20 meter accuracy certification, UL 61010 measurement safety, and utility revenue-grade approval programs
View ProductRuggedized Devices
IP67/IP68 ingress protection (IEC 60529), MIL-STD-810H environmental, IK impact rating, and FIPS 140-2 for secure government variants
View ProductData Loggers
FDA 21 CFR Part 11 and EU GMP Annex 11 compliance for pharmaceutical data loggers, plus FCC/CE for wireless variants
View ProductFirst-Attempt Pass Rate Above 90% Across 60+ Certifications
A 90%+ first-attempt pass rate results from integrating compliance into design reviews, not treating certification as a post-design step. Every failure across 60+ certifications feeds a lessons-learned library incorporated into checklists, so submission readiness is declared on pre-compliance data.
Multi-Market Parallel Submission Compresses Global Launch Timeline
Sequential certification — FCC first, then CE, then country-by-country — adds 6–12 months to global market entry. Ankh prepares samples, documentation, and fees for all markets simultaneously; a recent 8-market program compressed an 18-month sequential timeline to 7 months.
Certification Maintained Through Product Lifecycle, Not Just at Launch
Component substitutions and firmware updates carry re-certification exposure that blindsides teams treating certification as a one-time event. Regulatory impact is assessed before each change, minimum testing specified to keep grants valid, and annual UL inspections and BT SIG monitoring managed through the lifecycle.
Deliverables
Regulatory Scoping Matrix
Market-by-market table of required certifications, applicable standards, costs, timelines, and design constraints — updated at each revision milestone.
Pre-Compliance Test Report
Calibrated radiated and conducted emissions data with margin analysis, near-field source maps, and documented corrective actions before accredited lab submission.
FCC Grant of Equipment Authorization
FCC ID grant with all required exhibits, test reports, and labeling documentation — filed and tracked through TCB approval.
CE Technical File & Declaration of Conformity
CE technical file meeting RED, EMC, and LVD requirements — harmonized standard test reports, risk assessment, and signed DoC.
BT SIG QDID Listing & Wi-Fi Alliance Certificate
BT SIG end-product listing with referenced QDIDs, Declaration of Compliance, and logo license; Wi-Fi Alliance WFA ID certificate and authorized logo agreement.
Medical Device Technical File
510(k) submission package or EU MDR technical documentation — performance test reports, IEC 62304 software docs, ISO 14971 risk management file, and biocompatibility summary.
International Approval Certificates
Type approval certificates for IC, UKCA, MIC, KC, and CCC jurisdictions with labeling artwork and renewal calendar.
Certification Maintenance Register
Living register of all certifications with expiry dates, change impact log, inspection schedule, and documented change filings for post-approval engineering changes.
All certification deliverables are archived in a structured document management system with revision control, enabling rapid retrieval for post-market surveillance, regulatory audits, and market-access expansion.
Often Paired With Regulatory & Certification
RF & Wireless Engineering
Antenna design, RF optimization, and radio performance characterization tightly coupled with FCC, CE RED, and BT SIG certification requirements.
ExploreSystems Integration
System-level EMC pre-compliance testing during integration feeds directly into the certification test plan, eliminating duplicated effort.
ExploreElectronics Design
EMC design rules enforced during PCB layout review are the primary lever for first-attempt compliance in the accredited chamber.
ExploreProduct Strategy
Regulatory pathway plans and certification cost estimates from the strategy phase shape product architecture choices before design begins.
ExploreWork That Demonstrates the Standard
8-Market Wireless IoT Device Certified in 7 Months
The Wi-Fi module's existing FCC grant reduced scope to a change-in-ID, saving 8 weeks of testing; week-six pre-compliance caught a 2 dB margin loss at 2.4 GHz from a resonant PCB trace, resolved in a 3-hour layout fix. All 8 certifications (FCC, CE, UKCA, IC, MIC, KC, CCC, BT SIG) completed in 7 months.
Read the Case StudyClass II Medical Device 510(k) Cleared Without Additional Information Request
Ankh coordinated IEC 60601-1 NRTL testing, authored IEC 62304 software documentation, prepared the cybersecurity risk management file per FDA's 2023 guidance, and packaged a 990B-format eCopy for a Class II device with a custom analog front-end and AI algorithm. FDA issued clearance in 87 days without an Additional Information request.
Read the Case StudyReady to Certify Right the First Time?Compliance built in—not bolted on at submission.
A two-hour regulatory scoping session against your current design identifies the highest-risk certification gaps before your first prototype is built.