Technical Files & Dossier Preparation
Technical files and dossiers are documents that contain important information about medical devices, including the design, manufacture, testing, and performance of the device. They are typically required for the regulatory approval of medical devices, such as obtaining a CE mark for devices to be sold in the European Union (EU). Medical device regulations are constantly evolving, and companies must keep up with these changes in order to ensure that their technical files and dossiers are compliant.
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Medical device technical files and dossiers are comprehensive documentation that provide detailed information about a medical device, including its design, performance, and safety features. The preparation of these files and dossiers requires a thorough understanding of medical device regulations and standards, as well as expertise in technical writing and regulatory compliance.
To ensure the preparation of high-quality medical device technical files and dossiers, we offer the following services:
A medical device technical file contains a comprehensive set of documentation and information related to the design, development, testing, manufacturing, and clinical evaluation of a medical device. The specific contents of the technical file may vary depending on the classification of the device and the regulatory requirements of the region or country where the device will be marketed, but typically include:
- Device description and intended use
- Device design and development documentation, including risk management and design control documentation
- Material specifications and testing data
- Manufacturing and quality control documentation, including process validation and product testing data
- Clinical evaluation documentation, including clinical study reports and post-market surveillance data
- Labeling and packaging documentation, including instructions for use, warnings, and labeling translations
- Product registration and regulatory compliance documentation, including conformity assessment documentation, certifications, and post-market monitoring plans
- Device maintenance and servicing documentation
- Traceability and recall documentation, including batch/lot numbers and any reports of adverse events or complaints
- Device history records, including records of any modifications, maintenance, and servicing.
These documents collectively demonstrate that the medical device has been developed and manufactured in compliance with applicable regulatory standards and that it is safe and effective for its intended use.
This document provides a complete record of the design and development of the medical device, including design inputs, design outputs, verification and validation activities, and design changes.
In the United States, certain medical devices that have not been previously cleared by the FDA require a PMA application, which includes detailed information on the safety and efficacy of the device.
A 510(k) submission is required for certain medical devices that are similar to devices that are already on the market. The submission includes information on the similarities and differences between the new device and the predicate device.
These reports provide information on the safety and performance of the medical device after it has been commercialized, including adverse events, complaints, and any corrective or preventive actions taken.
These reports provide an overview of the safety profile of the medical device and any changes that have been made to the device or its labeling.
CERs provide an evaluation of the safety and efficacy of the medical device based on clinical data and other relevant information.
This document, which is required for certain classes of medical devices in the European Union, provides a summary of the safety and clinical performance of the device based on clinical data and other information.