Quality You Can Verify
Anyone can list logos. We give you certificates you can verify, backed by the same ISO 13485 quality system behind our home-use devices.
Quality · Service · Efficiency
Through a rigorous quality system, we continuously raise product quality;
sharpen efficiency to strengthen execution, and provide service that exceeds customer expectations.
Certifications & Compliance
Every certificate is verifiable; scans available under NDA.
Medical Devices QMS. Governs design, development, production, and servicing of medical-grade products with enhanced regulatory requirements.
Quality Management System. Ensures consistent product quality, process efficiency, and continuous improvement across all manufacturing operations.
European conformity declaration. Ensures health, safety, and environmental protection standards for products sold throughout the EU and EEA.
Documentation and testing support for your US submission: design records, component data, and third-party lab coordination. The filing stays with you as the brand owner.
Federal Communications Commission compliance. Required for electronics using radio frequencies sold in the United States market.
RoHS compliance, product-specific test reports, and market-specific certifications available on request per your regulatory requirements.
What a Certificate Proves, and What It Does Not
A certificate says a registrar audited a quality system on a given date. It does not say the scope covers your product, or that the system runs the way your programme needs. Four things are worth checking, on us or on anyone else.
Read the scope statement
The scope printed on an ISO 13485 certificate defines which products and activities were audited. A scope that stops short of your device category proves very little about your project.
Ask for the certificate, not the logo
Logos on a website are typography. Ask for the certificate scans, which we send under NDA, together with product-level test reports for the markets you sell in.
Probe traceability, not paperwork
Ask to walk a finished lot backwards, while you watch, to component lots, production records, and inspection results. A system that only produces documents after the fact will stall on this.
Read one closed CAPA record
Ask for a corrective action that closed. If it jumps from the problem straight to operator retrained with nothing in between, the same defect will come back.
What the Quality System Actually Does
Three inspection gates, plus third-party testing
Pre-production, in-process, and final outgoing inspection are separate gates with separate records. Third-party lab testing is coordinated where the destination market requires it.
A 33-point design review before any tooling is cut
Every project passes a design-for-X review scored red, amber, or green across 33 checks, and a single red stops the project until it is resolved. On one portable UV-C product that review raised six reds at once, including a 275 nm LED with a twelve-week lead time and a single source.
Complaints close the loop back to design
A field complaint on a home-use electronic device traced back to a USB Type-C connector overheating. The engineering change went from a 26-pin to a 6-pin connector with current sensing, the affected batches were traced, and the change rolled across sibling products.
What We Claim, Precisely
Our own certifications are ISO 13485:2016 and ISO 9001:2015. Everything else above is product-level compliance experience: CE, FCC, RoHS, PSE, UL, ETL, CB, CCC, BSMI, UN38.3, and SDS (MSDS) documentation. Capability and requirements vary by product and destination market, so ask us about yours specifically.
Certification Timeline
FCC & CE certifications achieved
ISO 9001 & ISO 13485 dual certification
Product-level certifications per market
Global compliance for 50+ countries
Related reading
ISO 13485 Contract Manufacturer: How to Verify One
What an ISO 13485 contract manufacturer does: traceability, DHR, design controls, and how to verify one when sourcing from Taiwan. Talk to our engineers.
Read more →FDA Documentation Support From Your Manufacturer
What FDA documentation support a contract manufacturer provides, and what it never does. The line between the brand's submission and the maker's evidence.
Read more →BSMI Certification: Selling Electronics in Taiwan
What BSMI certification covers: the RPC and DoC conformity paths, the inspection mark, and what else (NCC, TFDA) applies before you sell in Taiwan.
Read more →Come See the Factory Yourself
The fastest way to evaluate a manufacturing partner is to walk the floor. We host brand teams from the US, Europe, and Japan. Book a tour, or start with a quote.
Book a Factory Tour