Medical  Device  &  QA  Consultancy

TECHNICAL FILE

A TECHNICAL FILE is required for ALL PRODUCTS including Low Risk Class I and CUSTOM MADE devices….

We offer a SPECIAL DISTANCE STRATEGY to MANUFACTURERS of  CLASS I DEVICES with no measuring function and not supplied sterile.

The Distance Strategy we offer provides for;

· Provision of a Blank Technical File including full Index and easy to follow instructions to generate the required Data Content;

· All the necessary assistance to compile the data content;

· Review of Data content, prior to approval and issue as a controlled document;

· Full assistance in meeting all Post Sales Issues;

· All the above, for a minimum fixed cost;

· For a Quotation please fill out the  CONTACT US  Feedback Form.

IF YOU WISH TO UNDERTAKE THE TASK ENTIRELY BY YOURSELF…..

The following lists the TECHNICAL FILE content requirement of ANNEX VII and is good for CLASS I and CLASS IIa devices…

  Description of the device including Accessories and any Variants

  Clearly defined Intended Purpose / Intended Use

  Performance Claims backed by Clinical data, in accordance with Annex X clause 1.1 or clause 2.1, where applicable to your devices.

  Documented rationale for the Classification and Conformance Route.

  Results of Risk Management including Hazard Analysis and Risk Control

  Results of addressing the Essential Requirements of Annex I

  List of Standards applied in Full or Part

  Description of the Manufacturing Process including Procedures to “manufacture under controlled conditions”.

  List the Design Input Specified Requirements and show the Results of Design Verification

  List of Raw Materials used

  List of Constituent Component Parts

  Final Product documentation, (Labeling, Instructions for Use etc)

  Defined documentation retention period and Device Life

  Implement Procedures to effectively address Post Market Feedback/Surveillance, Vigilance / Incident Reporting, Complaint Handling, Advice Notice Issue and Product Recall.

  Procedure to maintain all relevant documentation (EG: ISO 9000:2000 cl 4.2.3 or  ISO 13485:2003 or both) including the Records to demonstrate that the Finished Product was manufactured under the “controlled conditions” referred to above.

  Make a Declaration of Conformity and include a Product Schedule

  Appoint an Authorized Representative if you are located outside Europe

  Register with the Competent Authority of the Country in which you will "Make the product Available"

Click here for a more formal Technical File CHECKLIST 

 For further information on any of the above items, please fax questions to CONTACT US