Overview

With the need of having clear, concise, and target audience-driven papers that comply with quality and regulation requirements, technical writing and the need for technical writers grew in popularity. The healthcare, pharmaceutical, and medical device manufacturing businesses, which span the world and adhere to international standards, have been major contributors. Medical Device Technical Files are summaries of data generated by the manufacturer to demonstrate the device’s safety and performance in a clear, well-organized, easily searchable, and understandable manner.

The technical data set is a collection of information for use in a regulatory application to establish that a product is safe and effective, as well as that you’ve met the CE Mark’s standards. MDR has specified what should be included in your technical documentation.
The sections below will provide you with more information. Medical device technical files come in a variety of forms, depending on the device’s manufacture.

TECHNICAL FILE CONTENTS – MDR 2017/745 – ANNEX II

• INTRODUCTION
• DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
• INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
• DESIGN AND MANUFACTURING INFORMATION
• GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
• BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT
• PRODUCT VERIFICATION AND VALIDATION
• CONCLUSION

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