The top-rated International Organization for Standardization (ISO) 13485 certification bodies include NQA, TÜV SÜD, Eurofins E&E, SGS and SCB, based on their accreditation, industry reputation, global reach and auditor experience. Their expert teams specialize in quality management system (QMS) certification for medical devices.
1. NQA
As an accredited certification and inspection body, NQA is one of the top-rated medical device certification bodies. Since 1988, it has issued over 53,000 certificates for both small businesses and multinational corporations. Its average client relationship is 10 years, demonstrating its commitment to successful collaboration.
Key Features:
- Provides certification, training and support.
- Offers online, classroom and in-house courses.
- Has competitive rates with no hidden fees.
2. TÜV SÜD
Since its founding in 1866, TÜV SÜD has issued over 670,000 certificates. As one of the leading global certification bodies, it has over 30,000 employees at 1,000 locations worldwide. Its audit team has deep medical device expertise, enabling it to provide comprehensive testing, inspection and certification solutions across all major medical device markets.
Key Features:
- Has a long history in the certification sector.
- Brings cross-industry expertise to the table.
- Offers testing, certification, auditing and advisory services.
3. Eurofins E&E
Regulatory compliance and certification body Eurofins E&E is an international network of accredited laboratories offering electronic compliance testing, inspection and certification. It helps clients bring medical devices to market on time and on budget.
Key Features:
- Has over 950 laboratories worldwide.
- Offers a range of testing and certification services
- Has six labs in the United States.
4. SGS
Accredited ISO 13485 certification body SGS is a leading provider of inspection, testing and certification services. Since 1878, it has grown into a global organization, with over 99,600 employees across 2,500 laboratories. Its full scope covers over 100 product categories, from imaging equipment to implantable devices.
Key Features:
- Supports continual business improvement
- Offers comprehensive, end-to-end certification support.
- Has a global network of professionals.
5. SCB
Full-service certification body SCB is accredited by the ANSI National Accreditation Board to multiple ISO standards, including ISO 13485. It provides QMS certification, auditing and compliance services to medical device manufacturers. With industry-specific expertise, it understands the importance of speed to market.
Key Features:
- Tailors its turnaround times to meet almost any deadline.
- Specializes in QMS certification for medical devices.
- Works with companies of all sizes.
What Makes These ISO 13485 Certification Bodies Stand Out?
These top-rated medical device certification bodies can help customers understand compliance requirements, confirm that medical device products meet the standards and provide proof of compliance through independent assessments. Their auditors are experienced with ISO standards and technically competent in medical device manufacturing.
Each company is accredited, ensuring its auditors are competent and their certification process is impartial. Most hold multiple accreditations from major industry regulators and accreditation bodies, demonstrating credibility and diligence. They are all transparent about their accreditation to minimize uncertainty.
Some of these ISO 13485 certification bodies are recognized Medical Device Single Audit Program auditing organizations, meaning they can conduct a single audit to satisfy the quality management system requirements.
Comparing Top-Rated Medical Device Certification Bodies
Any one of these companies can independently assess manufacturers’ quality management systems against the standard’s requirements. To narrow the selection down, decision-makers should evaluate each company’s foundation year and ISO 13485 accreditation, which indicate experience.
Service area is equally important. With specialists worldwide, medical device certification bodies can ensure compliance with diverse international standards. This enables customers to continue working with the same partner if they decide to enter a new market.
| Certification Body | Year Founded | ISO 13485 Accreditation | Global Reach |
| NQA | 1988 | Received in 2006 | Over 90 countries |
| TÜV SÜD | 1866 | Received in 2016 | Nearly 50 countries and territories |
| Eurofins E&E (Eurofins Scientific) | 1987 | Received in 2021 | Nearly 60 countries |
| SGS | 1878 | Unspecified | Over 115 countries |
| SCB (IAPMO) | 1926 | Received in 2023 | U.S., Mexico and Canada |
Frequently Asked Questions About ISO 13485 Certification
Here are the answers to frequently asked questions about ISO 13485 certification.
Why should I get ISO 13485 certified?
ISO 13485 is an internationally recognized quality management system standard that builds on ISO 9001:2015 principles. It ensures medical device manufacturers produce products that meet applicable laws and customer needs.
Getting certified by an independent third party is beneficial because it adds to the organization’s credentials. Aside from improving reputation and stakeholder relationships, it enhances risk management and expands procurement opportunities.
How does the ISO 13485 certification process work?
The certification process typically begins with a quote request form that helps the certification body understand the customer’s requirements and define the assessment scope. Once the company agrees to its proposal for certification, it books its assessment with an in-house auditor, who will conduct multiple visits.
Following a successful audit, the ISO 13485 certification body will make a decision. If it is positive, it will issue hard and soft copies of the certificate, which is valid for three years. To maintain certification, clients enroll in a program that includes annual maintenance audits and recertification audits.
Is ISO 13485 certification mandatory in the U.S.?
The U.S. Food and Drug Administration’s Quality Management System Regulation (QMSR) went into effect in February 2026. It amends the current good manufacturing practices and incorporates ISO 13485 by reference. This move harmonizes the agency’s regulatory framework with international regulatory authorities.
Manufacturers seeking to market medical devices in the U.S. must comply with the QMSR. While it aligns with ISO 13485, the two regulations are not equivalent. Compliance with the ISO standard does not necessitate compliance with QMSR. However, getting certified is still beneficial, as there is extensive overlap.
Choosing Between ISO 13485 Certification Bodies
Medical device manufacturers must manage increasingly complex global supply chains, strict market approval requirements, post-market surveillance and risk management across the product life cycle. Partnering with an ISO 13485 certification body can help them ensure their protocols are compliant. Decision-makers should consider company maturity, accreditation, auditor experience, service area and customer support hours when making their decision.
