What is design dossier?

What is design dossier?

Design dossiers refer to the technical documentation for Class III devices. Medical device companies are required to produce and maintain technical files for all of their products, and these documents are subject to review by Competent Authorities and Notified Bodies.

What is dossier in medical device?

For the purposes of WHO Prequalification – Diagnostics, the product dossier is a selection of records and documents compiled by a manufacturer from their existing records and documents to provide evidence that the IVD submitted for WHO prequalification conforms to the Essential Principles of Safety and Performance of …

What is a technical file MDD?

The medical device technical file is a must-have document for devices to be sold in the EU marketplace. The file contains detailed information about your medical device, its design, intended use claims, composition, and clinical evaluations.

What is a CE technical file?

The technical file represents a set of documents that demonstrate the conformity of a product with the CE-marking legislation. The documentation must specify the applicable product safety requirements and cover the design, manufacture, and operation of the product.

What is in a technical file?

Normally a technical file includes information about design, manufacture, and use of a product. In other words, it contains everything needed to show that the essential requirements of products bearing the CE marking have been met. What the technical file may include. A general description of the product.

What should dossier contain?

What is regulatory dossier and what does it contain?

• Figure 1.
• Cover Letter (Section 1.2)
• Field Copy Certification (Section 1.3)
• References (Section 1.4)
• Information Amendments (Section 1.11)
• Marketing Annual Reports (Section 1.13)
• Labeling (Section 1.14)
• Advertisements and Promotional Labeling Material (Section 1.15)

What should be in a technical file?

Technical File Information

• Description of the apparatus, usually accompanied by a block diagram.
• Wiring and circuit diagrams.
• General Arrangement drawing.
• List of standards applied.
• Records of risk assessments and assessments to standards.
• Description of control philosophy/logic.
• Datasheets for critical sub-assemblies.

What is in a device master record?

A DEVICE MASTER RECORD (DMR) CONTAINS ALL OF THE INFORMATION AND SPECIFICATIONS NEEDED TO PRODUCE A MEDICAL DEVICE FROM START TO FINISH, INCLUDING INSTRUCTIONS FOR ALL MANUFACTURING PROCESSES, DRAWINGS, DOCUMENTED SPECIFICATIONS AND LABELING AND PACKAGING REQUIREMENTS.

How do you write a technical file?

Once you’ve put your team together, writing technical documents comes down to a few simple steps.

1. Step 1: Do research and create a “Documentation Plan”
2. Step 2: Structure and design.
3. Step 3: Create the content.
4. Step 4: Deliver and test.
5. Step 5: Create a maintenance and update schedule.