Technical File
(for Medical Devices covered by directive 93/42/eec)
Version No. : ___________________
Report/File No. : ___________________
Issued On : Date/Month/Year
Copyright ? Company Name
Company Name.
Address line 1
Address line 2
Country
Telephone: +xxx-(xxx) xxxx-xxxx
Fax: +xxx-(xxx) xxxx-xxxx
Website: xxx.xxxxxxxxx.xxx
CONTENTS
Page Number
Contents x Executive Summary x 1. Product Specification x 1.1 Product Description x 1.2 Intended Purpose/Intended Use x 1.3 Product Family x 1.4 Performance Specifications x 1.5 Product Photographs/Drawings x 1.6 List of Standards Applied in full or part x 1.7 Pre-Production Design Input and Control x 1.8 Results of Design Verification x 1.9 Clinical Evaluation Data x 1.10 Packaging and Labeling x 1.11 IFU-Instructions for Use x
2. Manufacturer and Subcontractors x
2.1 Manufacturer x 2.2 Subcontractors x
2.3 Special Processes x
3. CE Marking Compliance x
3.1 European Authorized Representative x 3.2 Classification and Attestation Route x 3.3 Conformity Assessment Procedures x 3.4 Declaration of Conformity x 3.5 Lifetime of Product x 3.6 Retention of QA Records x 3.7 Retention of CA/NB Records x 3.8 Complaints Handling x 3.9 Advisory Notices and Recalls x 3.10 Vigilance System x 3.11 Post-Market Surveillance/Feedback x 3.12 Registration with Competent Authority x 3.13 Notified Body Intervention and Certifications x
4. Essential Requirements x 4.1 General Requirements x 4.2 Requirements Regarding Design and Construction x 4.3 Requirements Regarding Information Supplied by the Manufacturer x
5. Risk Assessment x 5.1 Risk Assessment x 5.2 Description and Identification of the Device x 5.3 Possible Hazards x
5.3.1 Energy Hazards x 5.3.1.1 Electricity x 5.3.1.2Heat x 5.3.1.3Mechanical force x 5.3.1.4Ionizing radiation x 5.3.1.5Non-ionizing radiation x 5.3.1.6Electromagnetic fields x 5.3.1.7Moving parts x 5.3.1.8Suspended masses x 5.3.1.9Patient support device failure x 5.3.1.10Pressure (vessel rupture) x 5.3.1.11Acoustic pressure x 5.3.1.12Vibration x 5.3.2Biological Hazards x 5.3.2.1 Bio-burden/bio-contamination x 5.3.2.2 Bio-incompatibility x 5.3.2.3 Incorrect output x 5.3.2.4 Incorrect formulation x 5.3.2.5 Toxicity x 5.3.2.6 Infection x 5.3.2.7 Pyrogenicity x 5.3.2.8 Hygienic safety x 5.3.3 Environmental Hazards x 5.3.3.1 Electromagnetic interference x 5.3.3.2 Inadequate supply of power coolant x 5.3.3.3 Restriction of cooling x 5.3.3.4 Operation outside environmental conditions x 5.3.3.5 Incompatibility with other devices x 5.3.3.6 Accidental mechanical damage x 5.3.3.7 Contamination due to device disposal x
5.3.4 Hazards Related to Use x 5.3.4.1 Inadequate labeling x 5.3.4.2 Inadequate operating instructions x 5.3.4.3 Inadequate specifications of accessories x 5.3.4.4 Over-complicated operating instructions x 5.3.4.5 Unavailable or separated operating instructions x 5.3.4.6 Use by unskilled/untrained personnel x 5.3.4.7 Human error x 5.3.4.8 Insufficient warnings of side effects x 5.3.4.9Inadequate warnings of hazards likely x
with re-use of single use devices x 5.3.4.10 Incorrect measurements and other metrological aspects x 5.3.4.11 Incorrect diagnosis x 5.3.4.12 Erroneous data transfer x 5.3.4.13 Mispresentation results x 5.3.5Hazards Arising from Functional Failure,
Maintenance and Ageing x 5.3.5.1 Inadequate performance x 5.3.5.2 Lack of specification for maintenance x 5.3.5.3 Inadequate maintenance x 5.3.5.4 Lack of adequate determination of end of device life x 5.3.5.5 Mechanical integrity x 5.3.5.6 Packaging x 5.4 Acceptability x 5.5 Risk Reduction x
Appendices Appendix A Appendix B Appendix C Appendix D Appendix E Appendix F Appendix G Appendix H Appendix I Appendix J Appendix K Appendix L Appendix M Appendix N Appendix O Appendix P Appendix Q Appendix R