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Quality & Compliance

ISO 13485 certification.

Structured, efficient, and sustainable. We guide medical device and IVD companies through the entire certification process: from the initial gap analysis to the issuance of the certificate.

Presentation of the ISO 13485 certificate following a successful audit

What is ISO 13485 certification? ISO 13485:2016 is the international standard for quality management systems in the medical device industry. Certification by an accredited body is a prerequisite for MDR conformity assessment by Notified Bodies and for market access in the EU, the U.S., and other regulated markets.

How can medtech manufacturers obtain ISO 13485 certification in 9 to 18 months?

ISO 13485:2016 is the international standard for quality management systems in the medical device industry and is effectively mandatory:

  • Notified bodies require an ISO 13485-certified QMS as a prerequisite for MDR certification.
  • Dealers, importers, and OEM partners are increasingly requiring proof of certification from suppliers.
  • Non-certified companies lose out on tenders and key B2B partnerships.
  • Implementing ISO 13485 without external assistance typically takes significantly longer and ties up a huge amount of resources.
Is your company already ISO 13485-certified, or are you currently planning to obtain your first certification?
Quality Engineer reviews ISO 13485 SOP documents

Our services for ISO 13485 certification.

We guide you through the entire process, from the initial assessment and the development of all necessary documentation and systems to the successful issuance of the certificate.

ISO 13485 Gap Analysis
A detailed audit of your existing quality management system (QMS) against the ISO 13485:2016 standard. You will receive a concrete action plan and a cost estimate.
QMS Design & Documentation
Development and adaptation of all necessary SOPs, forms, work instructions, and the Quality Management Manual (QMM)—practical, streamlined, and compliant with standards.
Rollout, Training & Internal Audit
Training your employees on the new processes. We conduct the legally required internal system audit as well as a mock audit to ensure optimal preparation for certification.
Support for the certification audit
Assistance in selecting a Notified Body, coordination of audit documents, and on-site support from our experts during Stages 1 and 2 of the certification audit.

Our path to ISO 13485 certification.

We guide you step-by-step through every stage—from the blank page to a successful certification audit.

01

Gap Analysis

A comprehensive assessment of your current QMS status against ISO 13485:2016. A prioritized action plan.

02

QMS Implementation

Implementation of all QMS elements: process definitions, SOPs, and forms using proven templates.

03

QMS Rollout

Training for all employees. Focus on establishing and developing internal audit expertise in a sustainable manner.

04

Mock Audit

Internal mock audit under real-world conditions. Identify and address any remaining vulnerabilities.

05

Certification audit

Coordination with the Notified Body and personal support during the external audit.

QM
“The biggest risk in the initial certification process isn’t the standard itself—it’s the internal processes that exist on paper but aren’t actually followed in practice. That’s exactly what every auditor checks first.”
Quality Management Team, ENTOURAGE

Frequently Asked Questions About ISO 13485 Certification.

How long does the initial ISO 13485 certification process take?
Typically 9 to 18 months—depending on company size, product complexity, and existing infrastructure. With ENTOURAGE’s support, schedule risks are identified early on, and structured milestones ensure steady progress.
How much does ISO 13485 certification cost?
The total cost consists of consulting services (implementation support) and certification fees charged by the accredited certification body. To provide a customized cost estimate, we need to conduct a brief assessment of your current situation.
How long is the ISO 13485 certificate valid?
The certificate is valid for 3 years. Annual surveillance audits are conducted during this period. After 3 years, a full recertification audit is required.
Can ISO 13485 certification be obtained at the same time as ISO 9001 certification?
Yes. Integrated audits for ISO 13485 and ISO 9001 are possible and more efficient than separate certifications. The combined audit saves time and money.
Is ISO 13485 mandatory for all classes of medical devices?
Technically, ISO 13485 is not required by law, but it is effectively indispensable: Notified Bodies require a certified QMS for MDR conformity assessment. Class I manufacturers also benefit, as many customers and distributors require certification.
Do you also provide support for surveillance and recertification audits?
Yes. We support you throughout the entire certification cycle: the initial audit, annual surveillance audits, and the recertification audit after three years. This includes assistance with internal audit preparation and management review.

Additional expertise in the area of Quality & Compliance.

Expertise

ISO Audit Consulting

Conduct internal audits and ensure thorough preparation for certification audits.

 Expertise

Quality Management

Establish QMS fundamentals, process design, and cross-system compliance.

 Expertise

Mock audits

Risk-free audit simulations under real-world conditions before the actual event.

Ready for ISO 13485 certification?

Get a structured roadmap for your initial certification. Our team will provide reliable support every step of the way, from the gap analysis to the presentation of your certificate.

Submit a project inquiry.

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