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Full Quality Assurance System Certificate Apostille & Legalization
Full Quality Assurance System
Digital / Online
Fast-track your global medical device distribution with expert federal authentication. A Full Quality Assurance System Certificate—typically issued by an EU Notified Body under Annex IX of the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR)—proves that your facility’s entire quality framework, from design and development to final manufacture and inspection, meets the highest international safety standards. When expanding into global medical markets, ministries of health outside the EU require this validated certificate to grant market clearance.
At US Apostille, we specialize in navigating the complex federal authentication process. We ensure your vital quality system credentials are processed flawlessly, securing your Federal Apostille or Embassy Legalization in just 9 business days.
We Accept Both Digital & Physical QA Certificates
In the highly regulated medical device sector, timing is everything. We accept both digitally-issued e-certificates and traditional paper documents to keep your global regulatory submissions on track.
1. Digital (PDF) Submission — Secure & Immediate
How it works: If your Notified Body (such as BSI, TÜV SÜD, DEKRA, or SGS) issued your Full Quality Assurance System Certificate as a secure digital PDF, you can upload the original file directly to our portal.
The Benefit: No printing or expensive international courier shipping. We verify the digital credentials and process the document directly for Federal Apostille.
2. Physical (Hard Copy) Submission
How it works: If your certificate has physical "wet-ink" signatures, official stamps, or holographic security seals, you must mail the physical document to our office.
When it is required: This step is mandatory if the destination country (such as China, Egypt, Saudi Arabia, or Brazil) requires a physical original for full Embassy Legalization.
Company Documents
⚠️ Federal Jurisdiction Notice
A Full Quality Assurance System Certificate is an international regulatory trade document. Therefore, it cannot be apostilled by a local state-level Secretary of State. It requires a Federal Apostille from the U.S. Department of State (Office of Authentications) in Washington, D.C.
Transparent Pricing & Turnaround Times
Document Type
Federal Fee
Service Fee
Total Cost
Processing Time
Full QA System Certificate
(Digital or Physical)
$20
$60
$80
9 Business Days
*Note: Processing times are subject to the U.S. Department of State’s current capacity. For non-Hague countries, additional Embassy fees and processing timelines will apply.
One-day apostille service for your company documents.
We obtain the apostille from the State of Maryland.
Regardless of which state your documents originated from.
Valid for use in all Hague Apostille Convention countries.
Processing time for all Company documents is
1
Business Day.
In real
6 days
US Department closes on Fri, Sat & Sun.
Order today by 4:00 PM
EST. We ship on
April 1, 2026
$50
per document + shipping
No extra fees.
Submit Your Company Documents
Click to select a file
Upload a
scanned copy of your document (PDF, JPEG, PNG)
Select your destination country and document type on the left to see your projected timeline and costs.
Why Medical Device Manufacturers Partner With Us
Regulatory Speed: We are fully integrated with modern e-certification standards to process your digital compliance files without shipping delays.
Direct Washington D.C. Presence: Located near the U.S. Department of State, we bypass standard mail-in delays to deliver fast, reliable federal authentications.
Global Medical Compliance Experts: We ensure your complex conformity and quality system certificates meet the precise, highly technical requirements of foreign ministries of health, customs authorities, and international registration bodies.
Frequently Asked Questions
No. A standard scan or photo of a physical paper document is not a digital original. You must provide the original, secure PDF issued electronically by your Notified Body, or mail the physical paper original to our office. The U.S. Department of State will reject standard scans.
For countries that are members of the Hague Apostille Convention, a Federal Apostille is all you need. However, major healthcare markets in the Middle East and Asia (such as Saudi Arabia, the UAE, or China) require a multi-step Embassy Legalization process after the Federal Apostille is complete. We handle this entire workflow for you.
Quality assurance system certificates are highly time-sensitive and tied to strict audit cycles. We prioritize these critical corporate files to ensure the authentication and legalization process is completed well before your current certificate or regulatory window expires.
Yes. We frequently process Full Quality Assurance System Certificates alongside Technical Documentation Assessment Certificates, Declarations of Conformity (DoC), ISO 13485 Certificates, and Certificates of Free Sale (CFS). We can authenticate your entire regulatory registration package together.
