Diverse business professionals standing together on a rooftop terrace overlooking a city skyline at

ISO 13485 Certification

Build trust with regulators, partners, and customers across medical device markets worldwide.

Quality management systems for medical devices and in vitro diagnostics

The international standard ISO 13485 forms the basis for the certification of quality management systems in companies that manufacture or distribute medical devices - or that are involved in their manufacture as part of the supply chain.

In terms of content, it addresses the requirements that medical device manufacturers and suppliers must meet in developing, implementing and maintaining management systems for the medical device industry.

Process reliability through documented procedures

Proof of compliance with legal requirements

Increased product safety for patients & users

Increased customer & employee satisfaction

Highlighting the competence of the company

Quality management systems for medical devices and in vitro diagnostics (SCC)

A quality management system forms the backbone for the activities and tasks of a medical device manufacturer. It ensures that internal and external regulations to be complied with are reliably taken into account and adhered to.

Appropriate certification enables a manufacturer to build confidence in its processes and products and demonstrate its commitment to safety and quality.

What is ISO 13485?

ISO 13485 is a stand-alone standard for quality management systems for manufacturers of medical devices or in vitro diagnostics, derived from the internationally recognized and accepted EN ISO 9000 series of standards. ISO 13485 continues the process-oriented approach of ISO 9001 and supplements it with specific aspects that are of particular importance for manufacturers of medical devices or in vitro diagnostic medical devices.

What are the contents of ISO 13485?

ISO 13485 supports manufacturers in developing a quality management system that enables safe and effective processes. These processes are designed to ensure the consistent design, development, production, installation, delivery, monitoring, tracking and disposal of medical devices, covering their entire product life cycle.

This is to ensure that medical devices and in vitro diagnostic medical devices can be used safely for their intended purpose.

What is the legal significance of ISO 13485?

Regulatory approval programs for medical devices or in vitro diagnostic medical devices are often based on requirements of ISO 13485. The general requirements of ISO 13485 are expanded and adapted to specific legal market requirements through concretizations and supplements.

What is the difference between ISO 13485 and EN ISO 13485?

While ISO 13485 is the internationally recognized basic version of the standard, it has been harmonized into a European standard by the European standardization body for its consideration in European regulatory approval procedures.

By complying with a harmonized standard, a manufacturer can prove that its products or services comply with the technical requirements of the relevant EU legislation and, if necessary, also claim the so-called presumption of conformity.

How does a certification according to (EN) ISO 13485 work?

In the first step, you discuss your company and the goals of an (EN) ISO 13485 certification with us. Based on these discussions, you will receive an individual offer tailored to the needs of your company or organization.

The assessment of your quality management system is carried out in stages using a system analysis (stage 1) based on your QMS documentation and a subsequent on-site system assessment (stage 2), in which an experienced assessor evaluates the effectiveness of your processes for compliance with applicable requirements. The results are presented to you at a final meeting, along with the next steps on the path to their certification. You will receive a detailed report summarizing the results once the next step certification decision has been made.

The results from your system assessment are evaluated by an independent panel of experts, who confirm or reject the assessor's certification recommendation. If there are any questions regarding the content, we will contact you.

If you can prove that all requirements have been met, you will then receive your (EN) ISO certificate.

In order to maintain your certification, we must carry out our surveillance activities at regular intervals in the form of an annual surveillance audit.

Should there be any changes to your quality management system within a certification cycle, we will adapt our surveillance activities accordingly and include them in the audit cycle.

A certification according to (EN) ISO 13485 has a maximum duration of three years, but you can seamlessly combine it with a subsequent audit cycle by applying for recertification.

What does certification according to (EN) ISO 13485 cost?

The costs of certification according to ISO 13485 depend primarily on the size of your company, but also on the complexity of your processes and your organizational structure. We will be happy to provide you with an individual offer.

Why should you have your company certified to (EN) ISO 13485 with DQS MED?

Recognized expertise in medical devices for more than 20 years
Active participation in standards and technical committees
Broad product portfolio of various normative and legal certification programs from one source
Worldwide network with over 200 experienced assessors and experts

ISO 13485 Certification with DQS — Sector-Experienced, Internationally Accredited, and Built for the Regulated Reality of Medical DevicesWith more than 40 years in management system certification, accreditations across every major market, and audit teams with deep medical device sector knowledge, DQS turns your ISO 13485 certification audit into a structured input for stronger processes — not a yearly hurdle to clear.

Key Benefits of Certifying ISO 13485 with DQS

Medical Device Expertise

Deep medical sector and regulatory knowledge, with auditors experienced in the realities of regulated production

EU MDR Notified Body

Backed by our recognition under the EU MDR, with direct experience of regulatory expectations in the medical device field

Global Market Recognition

ISO 13485 is a recognized QMS framework for medical device markets worldwide, supported by internationally accepted accreditations

Audits Built for Impact

Findings that go beyond confirming conformity and strengthen your quality management system

dqs-different people work together on a plan

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 practiceThe 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 customersFewer complaints and recalls supported by disciplined process controlFaster, more reliable market entry across regulated geographiesClearer accountability across design, manufacturing, and post-marketStronger 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.

Request Your Custom Offer

quality-management-dqs-three employees discuss process looking at ipad

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 devicesDevelopers of Software as a Medical Device (SaMD) and digital health solutionsSuppliers and contract manufacturers serving the medical device industrySterilization, packaging, and component service providers along the value chainImporters, distributors, and authorized representatives placing devices on regulated markets

DQS is Your Trusted Partner for ISO 13485 Certification

80 Offices in 60 Countries — Connected to the world, delivering services close to your needs.200+ Recognized Standards — Whatever your challenge, we offer certifications and assessment that fit and support your strategy.65,000+ Certified Sites — You’re in good company. Thousands of organizations trust DQS to certify what matters most.

9.40 Auditor Net Promoter Score (NPS) — Our customers consistently rate their audit interactions at an exceptional level.87% Recommendation Rate — A clear indicator of the confidence organizations place in our approach.Accredited Authority — Certifications backed by all relevant international accreditations and strict regulatory oversight.

Our Audit Approach

Audits aligned with your operational reality

We plan and conduct audits around how your medical device organization actually works, so the certification audit reflects your real processes across design, manufacturing, supplier control, and post-market.

Audits that go beyond certification

Beyond conformance, we highlight emerging risks and opportunities for improvement that strengthen your QMS and decision-making.

Constructive dialogue on eye level

Our medical device auditors combine deep sector knowledge with respectful, open exchange — never interrogation, always insight.

Digital by design

Streamlined, data-supported audit interactions — on-site, remote, or hybrid — make planning, execution, and follow-up more efficient.

ISO 13485 Certification processA clear process means fewer questions and faster results. These are the stages of your ISO 13485 certification with DQS — transparent from start to finish.

Once your ISO 9001 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, and the objectives you aim to achieve with your ISO 9001 certification. Based on this, you will promptly receive a detailed quote tailored to your individual needs. For complex certification processes, project planning can help coordinate timelines and audit execution across sites or departments.

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), your auditor evaluates the effectiveness of the management system processes on-site or through suitable remote techniques. 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.

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 9001 certificate of DQS.

To support continuous improvement and the ongoing effectiveness of your quality management system, key system components are audited at least once a year, during which potential areas for improvement are once again identified.

An ISO 9001 certificate is valid for three years. Well before expiration, a recertification is performed to confirm ongoing conformance with the ISO 9001 standard requirements. If all requirements of the standard are met, a new internationally recognized certificate will be issued.

Portrait of content candid manager man cross hands real boss ready decide work solution decision wea

In 3 Steps to an Offer for ISO 13485 Certification

You send your request in 1 minuteComplete the certification application documentsYou receive reliable quotes including audit planning“We typically respond within two business days with the next steps”

Request an offer

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.

ISO 13485 Certification Readiness Checklist

You Already Have a Certified Management System?

ISO 13485 combines naturally with other management system standards such as ISO 9001, ISO 14001, ISO 27001, or ISO/IEC 42001 — bundled certification reduces audit days, avoids duplicated effort, and gives your organization a single, coherent management framework.

Frequently Asked Questions about ISO 13485 Certification

Most organizations complete the ISO 9001 certification process within three to six months after their quality management system is fully implemented. The actual timeline depends on company size, the number of sites, scope complexity, and your audit-readiness. DQS plans a realistic schedule with you from initial inquiry to certificate issuance. Learn more on our ISO 9001 Knowledge Center page.

An ISO 9001 certificate issued by DQS is valid for three years. Continued validity depends on successful surveillance audits, which take place at least once a year and confirm that your quality management system remains effective. A recertification audit before the three-year mark renews the certificate for the next cycle. Learn more on our ISO 9001 Knowledge Center page.

The cost of ISO 9001 certification depends on your organization’s size, the scope of the management system, the number of sites included, and any industry-specific factors. Audit days follow accreditation rules and are calculated against standardized formulas, so quotes from accredited certification bodies are transparent and directly comparable. Request a personal quote to receive a tailored estimate for your specific scope.

Once your ISO 9001 management system is implemented, the external certification audit itself usually requires only a few days of on-site or remote audit time per site, plus internal preparation. The biggest driver of effort is the maturity of your processes and documentation — not the audit itself. DQS keeps your team’s involvement focused on what adds value through clear scope, efficient planning, and a modernized audit journey. Learn more on our ISO 9001 Knowledge Center page.

Request a quote

Your local contact person

"We would be happy to provide you with a customized offer for (EN) ISO 13485 certification."

Your inquiry