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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

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?

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 detailed report outlining prioritized actions, a timeline, and resource requirements.

02

QMS Implementation.

Implementation of all QMS elements: process definitions, SOPs, and forms. We provide proven document templates and customize them to meet your specific needs.

03

QMS rollout.

Training all employees on the new processes. Focus on ensuring long-term adoption and building internal audit expertise.

04

Certification audit.

Conducting an internal mock audit, coordinating with the certification body, and providing personal support during the final external certification audit.

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. ENTOURAGE also provides support for surveillance audits and recertifications.
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. A joint audit saves time and money—but requires an integrated QMS that is structured accordingly.

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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