Technical File Contents


Preparing Technical File is a tedious process. Proper understanding, Technical Knowledge & team efforts along with an experienced team of consultants are highly essential for the timely completion of medial device technical file or design dossier. Below table explain the technical file content / general format.

 

1.0TABLE OF CONTENTS
2.0NATURE OF AMENDMENT
2.1Issue Register
2.2Revision Register
3.0WARNING
4.0TECHNICAL FILE
5.0PURPOSE
6.0SCOPE
7.0COMPANY PROFILE
8.0DEFINITION OF TERMS
8.1Technical file
8.2Design Dossier
9.0MEDICAL DEVICE INFORMATION
9.1Device models and Variants
9.2Description of the Device
9.3Intended use of the Device
9.4Mechanism of Action
10.0DESIGN DOSSIER
10.1Device Drawings
10.2Device Specifications
10.3Design Approvals
10.4Design Transfer
10.5Bill of material
11.0MDD COMPLIANCE
11.1Classification and justification
11.2List of Applicable Directives
11.3List of Applicable MDD Guidelines followed
11.4List of Applicable Harmonized Standards
11.5List of Applicable Non-Harmonized Standards
11.6Use of Medical Substance
11.7Use of Animal Origin products
11.8Use of Blood or Blood Components
11.9Integration of a Medicinal Product into the Device
11.10Connection to other Devices
11.11Declaration of Conformity
11.12EC Representative
11.13Essential Requirement Check List
11.14Risk Analysis
11.15Post Market Surveillance (PMS)
11.16Post Market Clinical Follow-up (PMCF)
11.17Clinical Evaluation
12.0MANUFACTURING PROCESS
12.1Description of Manufacturing
12.2Description about critical process
12.3Environmental controls
12.4Critical suppliers
12.5Critical Process(validations)
12.6In-house Testing
12.7Pre- Clinical Testing
12.8Biocompatibility
12.9Electrical Safety
12.10Usability
12.11Sterilization
12.12Software Validation
13.0PRODUCT PACKING AND TRANSPORTATION
13.1Device Labeling
13.2Device Packing
13.3Storage and Transportation
13.4Packaging Validation
13.5Transportation Validation
13.6Device shelf life / Life Time