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Technical Documentation

EU Authorised Representation and Regulatory Solutions for Medical Devices and IVDs.

Technical Documentation MDR/IVDR

The EU MDR and IVDR set strict requirements for medical device manufacturers, requiring comprehensive technical documentation to demonstrate safety, performance, and quality compliance.

At Medunion, our technical file review services focus on critical elements including design and manufacturing data, risk management, clinical evaluation, post-market surveillance, labeling, and instructions for use. We ensure your documentation aligns with MDR/IVDR standards and provide detailed, actionable feedback to support full regulatory compliance.

Two professionals exchanging documents in an office setting, focusing on paperwork and data analysis.

Expert Technical File Review

We support medical device and IVD manufacturers with:

  • CE marking and EU regulatory compliance consultancy

  • Quality Management Systems according to EN ISO 13485

  • Risk Management in line with EN ISO 14971 and ISO 31000

  • Clinical evaluation and clinical investigations under EN ISO 14155

  • Regulatory affairs and submissions to the Spanish competent authorities

  • Preparation for and support during Notified Body audits

  • Review the quality and regulatory compliance status of your Spanish facilities through audits based on EN ISO 13485:2016 and the EU Medical Device Regulations.

  • Define a regulatory strategy, manage device registration, and ensure quality system compliance for your Spanish distributors and service providers.

Tailored Solutions

At Medunion, we help you bridge gaps and strengthen the quality of your technical documentation to meet EU MDR and IVDR standards. Our support is tailored to your product’s risk class, intended use, and regulatory pathway. Typical areas we assist with include:

papers, projects, documents, documentation, job, work, office, to do, limit, the norm, to perform, remodel, stack, to lie, work desk, business, invoice, payments, a lot, documents, documentation, documentation, documentation, documentation, documentation, job, limit, remodel, remodel, invoice, invoice, invoice

  • Design & Development Documentation
    Support with design inputs, outputs, reviews, verifications, and validations.

  • Test Report Review & Modernization
    Evaluation of existing reports with recommendations for alignment to current “state of the art” requirements.

  • Intended Use Evidence
    Justification and documentation of indications and contraindications based on scientific and clinical data.

  • Clinical & Performance Evaluation
    Gap analysis, literature review, and preparation of Clinical Evaluation Reports (CER) or Performance Evaluation Reports (PER).

  • Risk Management
    Risk file development and alignment with EN ISO 14971, integrated with the overall technical file.

  • Labelling & IFU Compliance
    Comprehensive review of labeling, symbols, packaging, and Instructions for Use (IFU) to ensure regulatory accuracy.

  • Post-Market Surveillance
    Assistance with PMS, PMCF, or PMPF activities—including planning, execution, and documentation.

  • Biocompatibility & Hazardous Substances
    Review of biological safety and use of CMR/ED substances, with alignment to Annex I requirements.

  • Quality Management System Integration
    Ensuring that your ISO 13485:2016 documentation supports and feeds into the technical file structure.

  • Specialist Device Support
    Regulatory guidance for high-risk or complex devices, including those incorporating medicinal substances or non-viable human/animal tissues.

Expertise that drives your success

Simplifying Regulatory Compliance for Medical Devices Across Europe.

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