CE Marking Services

At 60601Consult, Our team is dedicated to helping you navigate the complex regulatory landscape of the EU MDR and ensuring that your products meet the highest standards of safety and efficacy. we can help you ensure compliance with the EU MDR by providing expert guidance on all aspects of the regulation.

Depending on the development stage of your device, you can pick and choose or package the services that you want:

  1. Initial Gap assessment(FREE service): we will do an initial Gap assessment w.r.t to your current documentation and provide crucial information like device classification, establishing intended use, figuring out device standards at zero cost.

  2. Establish/Review QMS: we will review your current ISO 13485 QMS in the Free gap assessment and will provide pre-compliance services as per that assessment.

  3. Technical File: Technical file for the EU-MDR may feel like an endless list of documents (you can download the Free checklist from here). we will provide you with all sorts of compliance solutions like:

    1. DHF consulting

    2. Design verification/validation

    3. Developing specification requirements etc.

  4. Clinical Evaluation: we will help you create a Clinical evaluation plan, CER, and demonstrate clinical equivalence.

  5. Risk assessment: Risk assessment is a critical component of the risk management process outlined in ISO 14971. we will help you create a plan and an analysis report.

  6. Usability Studies: from formative to summative validation we will help you perform a Usability study as per IEC 62366 standards.

  7. Compliance Testing: we will help your device get tested by an accreditated third-party Laboratory on various standards such as IEC 60601 series of standards.

  8. Notified body assessment: we will help you with coordination with the Notified body till certification.

  9. EU REP: we will help you connect with a suitable EU representative.

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