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Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance
General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)
CE-marking process for medical devices CE-marking process for in vitro diagnostics MDR technical documentation checklist IVDR technical documentation checklist Technical documentation checklist for MDSW PRRC under MDR or IVDR
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Technical documentation


Facilitate your market entry with our services for CE marking and EU regulatory compliance.



Technical documentation is the cornerstone of ensuring compliance with MDR/IVDR and obtaining the CE marking. This documentation serves as a record that outlines the design, development, and performance of the device. It encompasses detailed information about the device's specifications, safety measures, risk assessments, and manufacturing processes.

The MDR and IVDR set stringent requirements for technical documentation, emphasising clarity, organisation, and unambiguous presentation.

Regulatory compliance plays a decisive role in market access process, while the technical documentation is the basis of regulatory compliance.

Our technical documentation solution includes the regulatory expertise, tailored services, and timely compliance to support your project.

Our technical documentation services


We specialise in providing technical documentation support tailored to your needs.

  • Technical documentation review
  • MDR/IVDR compliance assessment
  • Document gap analysis
  • Risk management file creation
  • Clinical evaluation support
  • Labeling and IFU development
  • Quality Management System integration
  • Post-market surveillance documentation
  • Periodic Safety Update Report (PSUR) preparation
  • Supplier and subcontractor documentation oversight
  • Regulatory intelligence updates
  • Technical documentation review
  • MDR/IVDR compliance assessment
  • Document gap analysis
  • Usability testing documentation
  • Risk management file creation
  • Clinical evaluation support
  • Labeling and IFU development
  • UDI implementation assistance
  • Quality Management System integration
  • Training on documentation requirements
  • Post-market surveillance documentation
  • Periodic Safety Update Report (PSUR) preparation
  • Medical Device Software (MDSW) socumentation
  • Supplier and subcontractor documentation oversight
  • Regulatory intelligence updates

How we attain compliance of technical documentation

Ensuring compliance of technical documentation with the MDR or IVDR involves a systematic approach starting with a gap analysis of existing documentation to identify disparities and areas needing enhancement to meet the requirements of MDR or IVDR.

We will reassess and strengthen you risk management system. This includes a detailed analysis of potential hazards, usability considerations, and post-market surveillance.

Clinical evaluation processes will be reviewed and augmented to gather robust clinical evidence supporting the safety and performance of the device, meeting the heightened expectations.

As a part of compliance procedure, labeling and instructions for use are scrutinised and refined to ensure clarity, comprehensiveness, and alignment with the requirements. Post-market surveillance processes are enhanced to ensure continuous monitoring of device performance and timely reporting of incidents or safety concerns.

Also, we will establish a system within your QMS for regular monitoring of regulatory updates to ensure that documentation remains current and aligned with evolving standards.

MDR/IVDR compliant technical documentation

Ensuring compliance of technical documentation with the MDR or IVDR involves a systematic approach starting with a thorough gap analysis of existing documentation to identify disparities and areas needing enhancement to meet the stringent requirements of MDR or IVDR.

Risk management processes are reassessed and strengthened to align with the elevated expectations. This includes a detailed analysis of potential hazards, usability considerations, and post-market surveillance. Clinical evaluation processes are reviewed and augmented to gather robust clinical evidence supporting the safety and performance of the device, meeting the heightened expectations.

Labeling and instructions for use are scrutinized and refined to ensure clarity, comprehensiveness, and alignment with the requirements. Post-market surveillance processes are enhanced to ensure continuous monitoring of device performance and timely reporting of incidents or safety concerns.

Regular monitoring of regulatory updates is established to ensure that documentation remains current and aligned with evolving standards. Proactive engagement with Notified Bodies is crucial to seek guidance on compliance requirements and receive timely feedback on documentation improvements.

Stakeholder training is provided to enhance awareness of MDR or IVDR requirements and their implications on documentation. The process is iterative, requiring regular revisiting and refinement based on feedback, changing regulations, and the evolving understanding of device performance.

MDR/IVDR compliant documentation essentials

MDR/IVDR compliant technical documentation is a set of documents that must meet the regulatory requirements and ensure compliance with MDR or IVDR.

Main sections of MDR/IVDR compliant technical documentation

The structure of technical documentation sets the stage for subsequent sections that delve into risk management, usability, and clinical evaluation.





The main sections of MDR/IVDR compliant technical documentation are as follows:

  • Device description and specification
  • Information supplied
  • Design and manufacturing
  • GSPR and applied standards
  • Risk management
  • Product verification and validation
  • Post market surveillance

MDR/IVDR compliant documentation essentials

MDR/IVDR compliant technical documentation includes essential documents such as risk management files, clinical evaluation reports, labeling and instructions for use, post-market surveillance data, and evidence supporting device safety and performance. This set of documents is designed to meet the stringent regulatory requirements and ensure compliance with the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR).

Main sections of MDR/IVDR compliant technical documentation

At its core, MDR-compliant technical documentation includes a comprehensive overview of the medical device, outlining its intended use, specifications, and principles of operation. This foundational information sets the stage for subsequent sections that delve into risk management, usability, and clinical evaluation. The main sections of MDR/IVDR compliant technical documentation are as follows:

When it comes to technical documentation, the thrill lies in the precision, the artistry of compliance, and the satisfaction of creating documents that not only meet regulations but propel groundbreaking technologies into the hands of those who need them.

Send us an email:
info@mdrc-services.com

Or use the contact form below

 

Send us an email:
info@mdrc-services.com

Or use the contact form below