Docstoc

Preparation of a Technical File

Document Sample
Preparation of a Technical File Powered By Docstoc
					           [Company Name]
           [Company Group, Division, Location]


           Document Title: Preparation of a Technical File
           Document Number:     [Document Number]
           Document Filename:   [Document Filename]




                                                                     CONTROLLED COPY/ MASTER COPY
                                                                             STAMP HERE




                                                                               OTHER
                                                                             STAMP HERE




Revision   Revision     DCO/ECO                                                     Revision
Level      Date         Number       Description of Revision                        Author
DRAFT      DD/MM/YY     YY-00000     Draft                                          Author Name
1.00       DD/MM/YY     YY-00000     Initial Release                                Author Name




                                    COMPANY PROPRIETARY AND CONFIDENTIAL
[Company Name]                                                                                                               Preparation of a Technical File
[Company Group, Division, Location]                                                                                                   [Document Number]
                                                                                                                                      Rev x.xx DD/MM/YY




Table Of Contents

1.0    Purpose ........................................................................................................................................................ 2

2.0    Scope ........................................................................................................................................................... 2

3.0    Definition Of Terms ..................................................................................................................................... 2
       3.1 Design History File (DHF) ................................................................................................................ 2
       3.2 Device Master Record (DMR) .......................................................................................................... 2
       3.3 Medicinal Product ............................................................................................................................. 2
       3.4 Technical File .................................................................................................................................... 2

4.0    References.................................................................................................................................................... 2

5.0    Responsibilities and Requirements .............................................................................................................. 2

6.0    Procedure and Contents ............................................................................................................................... 2
       6.1 Technical File Format ....................................................................................................................... 2
       6.2 Preparation of Technical File ............................................................................................................ 3
       6.3 Technical File Contents..................................................................................................................... 3
             6.3.1   Declaration of Conformity .................................................................................................. 3
             6.3.2   General Description ............................................................................................................ 3
             6.3.3   Design Specifications.......................................................................................................... 3
             6.3.4   Essential Requirements ....................................................................................................... 3
             6.3.5   Results of Risk Analysis ..................................................................................................... 3
             6.3.6   Techniques to Control and Verify the Design and Processes .............................................. 3
             6.3.7   Connections to Other Devices............................................................................................. 3
             6.3.8   Use of Medicinal Product ................................................................................................... 3
             6.3.9   Integration of a Medicinal Product into the Device ............................................................ 3
             6.3.10 Clinical Data ....................................................................................................................... 3
             6.3.11 Device Labeling .................................................................................................................. 4
             6.3.12 Instructions for Use ............................................................................................................. 4
             6.3.13 Sterilization Processes and Procedures ............................................................................... 4
             6.3.14 Purchasing Procedures ........................................................................................................ 4
             6.3.15 Product Identification Procedures During Manufacture ..................................................... 4
             6.3.16 Tests and Frequency Before Manufacture .......................................................................... 4
             6.3.17 Tests and Frequency During Manufacture .......................................................................... 4
             6.3.18 Tests and Frequency After Manufacture ............................................................................. 4
             6.3.19 Test Equipment ................................................................................................................... 4
             6.3.20 Test Equipment Calibration Records .................................................................................. 4
             6.3.21 Design Dossier (Class III Medical Device Only) ................................................................ 4
             6.3.22 Design Examination Certificate (Class III Medical Device Only) ...................................... 4
       6.4 Review of the Technical File............................................................................................................. 4
       6.5 Documenting the Technical File ....................................................................................................... 4




[Document Filename]                                COMPANY PROPRIETARY AND CONFIDENTIAL                                                                   Page 1 of 4
[Company Name]                                                                         Preparation of a Technical File
[Company Group, Division, Location]                                                             [Document Number]
                                                                                                Rev x.xx DD/MM/YY




1.0    Purpose
       This document defines the contents of and procedures for creating a Technical File in accordance with
       Annex I (Essential Requirements) and Annex H (Declaration of Conformity) of the Medical Devices
       Directive, 93/42/EEC.

2.0    Scope
       This procedure applies to all product development programs for medical devices funded and managed by
       [Company Name].

3.0    Definition Of Terms

       3.1    Design History File (DHF)
              A compilation of records that describes the design history of a finished product.

       3.2    Device Master Record (DMR)
              A compilation of records containing the procedures and specifications for a finished product.

       3.3    Medicinal Product
              Any substance or combination of substances presented for treating or preventing disease in human
              beings or animals. Likewise considered a medicinal product is any substance or combination of
              substances that may be administered to human beings or animals with a view to making a medical
              diagnosis or to restoring, correcting, or modifying physiological functions in human beings or in
              animals.

       3.4    Technical File
              A compilation of documents and technical files demonstrating development of a product in
              accordance with the ISO-9001 International Standard, Section 4.4 (Design Control), and
              compliance to the "essential requirements" set forth in the Medical Devices Directive, 93/421EEC,
              Annex I.

4.0    References
            Medical Devices Directive (MDD), 93/421EEC
            The Product Development Cycle
            Design History File

5.0    Responsibilities and Requirements
       [Insert the roles and responsibilities for the various positions that are involved with the preparation of a
       technical file. Such positions as: the Business Management Team, Program Manager, Quality Systems
       Manager, Technical Advisory Team, etc.]

6.0    Procedure and Contents
       [Insert the procedures and policies associated with preparing a technical file. Include:
              A description of the Technical File Format; it describes the product information and
              documentation requirements. It is advised to use the technical file checklist to verify that all
              appropriate information is included in the technical file. State on each item of the checklist
              whether the item is applicable or not applicable.

       6.1    Technical File Format
              Use the approved Technical File Checklist to compile the Technical File. The checklist provides a
              process to verify that the required documentation is compiled in the Technical File. This procedure
              describes the product information and documentation requirements listed on the checklist. If it is
              applicable to this product, cite the document (file name, number, etc.) demonstrating compliance
              with the requirement and its location.

[Document Filename]                   COMPANY PROPRIETARY AND CONFIDENTIAL                                 Page 2 of 4
[Company Name]                                                                        Preparation of a Technical File
[Company Group, Division, Location]                                                            [Document Number]
                                                                                               Rev x.xx DD/MM/YY



       6.2    Preparation of Technical File
              [Insert information that should be compiled on the technical file checklist, such as:
                        Device Name, Classification
                        Name of the File and location, letter of revision, the name of the individual compiling the
                        checklist, date.

              Also include the person who compiles the checklist and the technical file along with those that
              contributed input or information].

       6.3    Technical File Contents

              6.3.1     Declaration of Conformity
                        Provide the completed Declaration of Conformity in accordance with Annex H (Full
                        Quality Assurance System) of the Medical Devices Directive. The Quality Systems
                        Manager is responsible for preparing the Declaration of Conformity.

              6.3.2     General Description
                        Provide document(s) giving a general description of the medical device including method
                        of operation, intended use, and other details generally describing the product and its
                        intended use. Also provide descriptive information related to any variants of the product.

              6.3.3     Design Specifications
                        Provide the Design Requirements Document and system, subsystem, and critical
                        component specification documents.

              6.3.4     Essential Requirements
                        Provide the completed Essential Requirements Checklist for this medical device and any
                        required supporting documentation. See the applicable harmonized standards contain
                        technical details of the Essential Requirements.

              6.3.5     Results of Risk Analysis
                        Provide completed technical report(s) and other documentation detailing results of risk
                        analysis for this medical device.

              6.3.6     Techniques to Control and Verify the Design and Processes
                        Provide the Standard Operating Procedures related to design control in accordance with
                        section 4.4 of the ISO-9001 standards.

              6.3.7     Connections to Other Devices
                        If the medical device must be connected to another device in order to perform its intended
                        use, provide the completed Essential Requirements Checklist for this device combination
                        and any required supporting documentation.

              6.3.8     Use of Medicinal Product
                        If applicable, provide a statement that the device incorporates a medicinal product as an
                        integral part of its operation. Describe the medicinal product and application in the use of
                        this device.

              6.3.9     Integration of a Medicinal Product into the Device
                        Provide test data validating the integration of a medicinal product into the device.

              6.3.10 Clinical Data
                     Provide the data and results of the clinical trial to validate the medical device and its
                     intended use in accordance with Annex X of the Medical Devices Directive.

[Document Filename]                   COMPANY PROPRIETARY AND CONFIDENTIAL                                Page 3 of 4
[Company Name]                                                                       Preparation of a Technical File
[Company Group, Division, Location]                                                           [Document Number]
                                                                                              Rev x.xx DD/MM/YY



              6.3.11 Device Labeling
                     Provide all documentation related to the labeling of the medical device including
                     packaging, labels, manuals, etc.

              6.3.12 Instructions for Use
                     Provide the user's instructional manual and any other instructional manuals packaged with
                     medical device.

              6.3.13 Sterilization Processes and Procedures
                     Provide documentation describing the processes and procedures for sterilizing the
                     medical device before packaging, shipment, and/or use.

              6.3.14 Purchasing Procedures
                     Provide documentation describing procedures for purchasing components to manufacture
                     the medical device.

              6.3.15 Product Identification Procedures During Manufacture
                     Provide documentation describing procedures for identifying, tracking, and controlling
                     the product through the manufacturing process.

              6.3.16 Tests and Frequency Before Manufacture
                     Provide documentation describing procedures for verifying conformance and quality of
                     components and subsystems before manufacturing the device.

              6.3.17 Tests and Frequency During Manufacture
                     Provide documentation describing procedures for verifying conformance and quality
                     while manufacturing the device, including frequency of tests.

              6.3.18 Tests and Frequency After Manufacture
                     Provide documentation describing procedures for verifying conformance and quality after
                     the device is manufactured, including frequency of tests.

              6.3.19 Test Equipment
                     Provide documentation describing the equipment used for the above tests.

              6.3.20 Test Equipment Calibration Records
                     Provide documentation describing calibration of the test equipment.

              6.3.21 Design Dossier (Class III Medical Device Only)
                     Prepare a Design Dossier in accordance with the Medical Devices Directive. The Design
                     Dossier is the Technical File plus the Device Master Record for that product.

              6.3.22 Design Examination Certificate (Class III Medical Device Only)
                     The notified body prepares the Design Examination Certificate after review of the
                     Technical File.

       6.4    Review of the Technical File
              [Specify who will be reviewing the technical file before it is submitted. Discuss the role and
              responsibility of the individuals that are reviewing and submitting the file.

       6.5    Documenting the Technical File
              [Specify who documents the technical file and the checklist and where it will be stored].



[Document Filename]                   COMPANY PROPRIETARY AND CONFIDENTIAL                                Page 4 of 4

				
DOCUMENT INFO