Certify with the audit partner that understands the regulated reality of medical devices.
From single-site manufacturers to global medical device groups, DQS audits quality management systems against the requirements of ISO 13485, with sector[1]experienced auditors who understand the realities of regulated production worldwide. Supported by internationally recognized accreditations, including DAkkS, ANAB and the Standards Council of Canada, as well as Notified Body experience under the EU MDR, DQS provides independent certification for demonstrating compliance, building trust and preparing for market access.
Medical Device Expertise
— Deep medical sector and regulatory knowledge.
EU MDR Notified Body
— Backed by our recognition under the EU MDR.
Global Market Recognition
— ISO 13485 is a recognized QMS framework for medical device markets worldwide.
Audits With Business Impact
— Insights that go beyond confirming conformity.
Certification That Opens Regulated Markets
A certified ISO 13485 management system is more than a regulatory checkbox — it’s how medical device organizations show, in a structured and traceable way, that quality is built into every process. With DQS as your certification partner, your audit becomes an opportunity to sharpen your QMS, reinforce confidence among regulators and partners, and support sustained access to demanding markets.
Typical Effects of ISO 13485 Certification in practice
The value of certification extends beyond external proof of conformity. Many organizations use recurring audits and assessment processes as a framework for continuous improvement, operational transparency, and stronger cross-functional alignment. In practice, companies often report effects such as:
- Smoother interactions with regulators, Notified Bodies, and customers
- Fewer complaints and recalls supported by disciplined process control
- Faster, more reliable market entry across regulated geographies
- Clearer accountability across design, manufacturing, and post-market
- Stronger supplier oversight throughout the medical device value chain
Start ISO 13485 Certification with DQS Now
Save time and internal effort with a clearly structured certification process. Request your personal quote for your ISO 13485 certification now.
Who Will Benefit from ISO 13485 Certification
ISO 13485 is the internationally recognized quality management standard for organizations involved in the medical device life cycle. It is the reference framework behind major regulatory regimes, including the EU MDR and IVDR, MDSAP, and, since February 2026, the US FDA Quality Management System Regulation which incorporates ISO 13485:2016 by reference. Certification is particularly relevant for:
- Manufacturers of medical devices, in vitro diagnostics (IVDs), and active implantable devices
- Developers of Software as a Medical Device (SaMD) and digital health solutions
- Suppliers and contract manufacturers serving the medical device industry
- Sterilization, packaging, and component service providers along the value chain
- Importers, distributors, and authorized representatives placing devices on regulated markets
DQS is Your Trusted Partner for ISO 13485 Certification
Our Audit Approach
ISO 13485 Certification process
A clear process means fewer questions and faster results. These are the stages of your ISO 13485 certification with DQS — transparent from start to finish.
From inquiry to quotation
Once your ISO 13485 management system has been implemented across the organization, it is ready for certification. You will go through a multi-stage certification process at DQS. Your initial interaction will involve discussing your organization, your quality management system for medical devices, and the objectives you aim to achieve with your ISO 13485 certification. Based on this, you will promptly receive a detailed quote tailored to your individual needs. For complex certification processes — such as multi-site manufacturers or organizations seeking integrated audits with adjacent regulatory schemes — project planning can help coordinate timelines and audit execution across sites or departments.
ISO 13485 Certification audit: Stage 1 and Stage 2
The certification audit begins with a system analysis (stage 1 audit) as well as an evaluation of your documentation, the results of your management review, and your internal audits. The goal is to determine whether your management system is adequately developed and ready for certification. In the next stage, the system audit (stage 2), our auditors evaluates the effectiveness of all management system processes on-site or through suitable remote techniques — covering critical medical device areas such as design and development controls, risk management, production and process controls, CAPA, and post-market surveillance. After the audit is completed, you will receive a detailed presentation of the results in a closing meeting, along with information on potential areas of improvement for your company. If necessary, action plans for improving your management system will be agreed upon.
ISO 13485 Certificate
After the certification audit, the results are evaluated by the independent certification body of DQS. You will receive an audit report documenting the audit results. If all standard requirements are met, following a positive certification decision, you will receive the accredited ISO 13485 certificate of DQS.
Surveillance audits
To support continuous improvement and the ongoing effectiveness of your quality management system, key system components are audited on-site at least once a year, during which potential areas for improvement are once again identified.
ISO 13485 Re-Certification
An ISO 13485 certificate is valid for three years. Well before expiration, a recertification is performed to confirm ongoing conformity with the ISO 13485 standard requirements. If all requirements of the standard are met, a new internationally recognized certificate will be issued.
In 3 Steps to an Offer for ISO 13485 Certification
- You send your request in 1 minute
- Complete the certification application documents
- You receive reliable quotes
Certification Readiness
Is your company ready for ISO 13485 Certification?
- Your medical device quality management system is implemented across all relevant sites and processes.
- Document and record control are operational, covering design, production, and post-market files.
- A risk management process aligned with ISO 14971 is established and integrated into your QMS.
- Training, competence, and responsibilities are defined and documented.
- Supplier control, CAPA, complaint handling, and feedback processes are established.
- Required validation activities have been completed, where applicable.
- A full cycle of internal audits has been completed and findings have been addressed.
- A documented management review has taken place and resulting actions are being tracked.
If your organization meets these conditions, you are ready to contact DQS to begin your certification process.
You already have a Certified Management System?
ISO 13485 can be combined efficiently with related schemes such as ISO 9001, ISO 14001, ISO 27001, or ISO/IEC 42001 — reducing parallel audit days, simplifying documentation, and giving you one consistent view across your management systems.
Frequently Asked Questions about ISO 13485 Certification
How long does ISO 13485 Certifcation take?
The duration depends on the size of your organization, the complexity of your product portfolio, and the maturity of your existing management system. As a conservative estimation, for a typical medical device manufacturer, the path from initial inquiry to issued certificate often takes between six and ten months, including stage 1 and stage 2 audits and the certification decision. However, the timeline may be shorter or longer depending on the factors described above. Learn more in our ISO 13485 Knowledge Center.
How long is an ISO 13485 Certification valid?
An ISO 13485 certificate issued by DQS is valid for three years. Annual surveillance audits confirm the continued effectiveness of your medical device quality management system, and a recertification audit before the three-year mark renews your certificate for the next cycle. Learn more in our ISO 13485 Knowledge Center.
What does an ISO 13485 Certification cost?
Certification fees depend on factors such as company size, number of sites, scope of medical device activities, and the complexity of your product range. DQS provides individual, transparent quotes after a short scoping conversation, no hidden fees, no obligation. Request a quote for your ISO 13485 certification.
What is the effort involved in achiving ISO 1385 Certification for my company?
The main internal effort lies in implementing and maintaining the management system itself, design controls, risk management, supplier oversight, CAPA, and post-market activities. Once your system is in place, the audit-related effort is structured and predictable, with clear stages and defined inputs from your team. Learn more in our ISO 13485 Knowledge Center.