Technical Documentation & Submissions

We specialize in offering comprehensive support for medical device documentation and submissions ensuring that every aspect of your technical files meets global standards. Our services streamline the process from documenting to regulatory submission, helping you achieve market success.

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Comprehensive Regulatory Support for Medical Device Documentation

DDReg’s team of experienced regulatory professionals provides end-to-end support in preparing and reviewing the necessary documentation. Our experts conduct detailed gap analysis ensuring your documents are aligned with the latest regulatory requirements. With a focus on precision, we help you produce quality documentation that facilitates smoother review processes.

DDReg enhance your submissions by integrating best practices in technical documentation for medical devices. Our services also extend to overseeing the medical device development documentation lifecycle, ensuring that every detail from design to market is thoroughly documented and compliant.

Medical Devices Technical Document Management Solutions
Medical Devices Technical Documentation Submission

Advanced Medical Devices Document Management Solutions

Our advanced document management solutions combine strategic planning with practical expertise. We support the creation and maintenance of Design History Files (DHF) and conduct comprehensive gap analysis and remediation. This robust approach ensures that your technical files remain current and aligned with evolving standards, from EU MDR to IVDR requirements.

In addition, we offer complete support in preparing Clinical Evaluation Reports (CER) and provide apostille, legalization, and notarization services. Our guidance covers all aspects of Medical Device Documentation & Submissions, ensuring your submission package is complete, accurate, and ready for regulatory review.

Contact our expert team today to get started on your Medical Device Documentation & Submissions and propel your product to global market success!

Our Technical Documentation & Submission Expertise

  • Gap analysis from EU MDD to EU MDR
  • Design History File (DHF) Creation & Maintenance (Compilation, Gap Analysis and Remediation)
  • Technical File Compilation (EU MDR/IVDR)
  • CER (Clinical Evaluation Reports)
  • Apostille, Legalization, Notarization
  • Regulatory Submissions (510(k), EU MDR, UKCA, Other Global Regulatory Submission)
  • Artwork / Labelling / Technical Writing Services / Translation
  • CE Certification

Ready to optimize your regulatory process and ensure flawless document submissions?

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