CE MARKING

 We assist you in preparing complete technical documentation, ensuring conformity with European regulations, and obtaining CE marking efficiently (MDR 2017/745 & IVDR 2017/746)

Our Objective

Our objective in Europe is to support medical device and digital health companies in achieving robust, compliant, and sustainable market access within a highly regulated and harmonized framework. We help our partners navigate the requirements of the EU MDR, IVDR, and related national provisions, anticipate regulatory changes, and implement clear, efficient compliance strategies. Through expert guidance and end-to-end regulatory support, we ensure that innovative technologies reach patients safely, efficiently, and in full alignment with European competent authorities and notified bodies.

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Latest Updates

Stay informed with the most recent changes impacting CE Marking, European regulations, and medical device requirements. This section features key regulatory updates, guidance changes, standards revisions, and important announcements that help you keep your compliance strategy aligned with evolving EU expectations.

Our Services

we support medical device manufacturers in navigating EU regulatory requirements, from initial compliance to ongoing lifecycle management.

Our services are tailored to Quality, Regulatory, R&D and Manufacturing teams who need practical, efficient support to comply with EU MDR and related standards.

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EU Regulatory Compliance Consulting & Gap Audits

We help you assess and improve your compliance with EU MDR and related requirements through targeted consulting and structured audits.

Typical support includes:

  • MDR gap assessments (technical documentation, PMS, vigilance, labeling, clinical evaluation, etc.).

  • Review of your existing documentation and processes against EU MDR expectations.

  • Internal audits focused on MDR and ISO 13485 requirements.

  • Action plans with clear priorities and practical recommendations.

Deliverables may include an audit report, a gap analysis matrix and a step‑by‑step remediation roadmap.

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Templates & Support for EU Documentation

We provide ready‑to‑use documentation templates aligned with EU MDR and ISO 13485, combined with expert support to adapt them to your devices and organization.

Examples of templates and toolkits:

  • Technical documentation structure (Annex II & III).

  • GSPR (General Safety and Performance Requirements) matrix.

  • PMS (Post‑Market Surveillance) plan and related documentation.

  • Core quality management procedures and forms.

You can:

  • Start with available templates and extend your toolkit over time.

  • Work with us to adapt each template to your product portfolio and risk profile.

  • Reduce the time spent drafting documents from scratch while ensuring consistency.

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Training on EU MDR, ISO 13485 and Documentation

 We offer training sessions tailored to your teams and your level of maturity.

Possible training topics include:

  • Introduction to EU MDR requirements for manufacturers.

  • Building and maintaining MDR technical documentation.

  • Key ISO 13485 requirements and their practical implementation.

  • Roles and responsibilities for Quality, Regulatory, R&D and Manufacturing in compliance.

Training can be delivered online or on site (where applicable) and can be adapted for different audiences (management, operational teams, new staff).

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EU Authorised Representative Services

For manufacturers located outside the European Union, we can act as your EU authorised representative through our partners or dedicated arrangements.

This service may include:

  • Acting as your official contact point with EU authorities and competent bodies.

  • Holding and maintaining required documentation for your devices.

  • Supporting communication related to vigilance, field safety corrective actions and regulatory questions.

  • Ensuring that your obligations as a non‑EU manufacturer are understood and fulfilled.

The scope of authorised representation is defined contractually, in line with MDR requirements.

250+ CE-marked devices

Covering all risk classes — from Class I to Class III.

Let our regulatory specialists handle the complexity of CE marking so you can focus on innovation and growth.

Ready to accelerate your CE marking process?

Make An Appointment

Our experienced consultants are available to discuss your project and tailor a strategy that fits your needs.

Book An Appointment
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