About The Technical File Consultant Service

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The Medical Device device manufacturers are advised to start working on revising the CE Marking Technical regardless of Notified Body. The (Medical Device Single Audit Program) MDSAP Consultant is designed to quality system compliance and it is allowing device companies to meet requirements in participating markets through a single audit. Now that the pilot phase of the program is over, more companies are seeking MDSAP Consultant certification to expand their market reach. This  Certificate will be issued by Notified Body after a thorough review of Technical File Documentation.

Ø  Technical File Consultant Service

The Technical File Consultant should be prepared and submitted to Notified Body by the manufacturer. The new Medical Devices Regulation and In Vitro Diagnostic Regulation and it has a lot of additional requirements compared to MDD which is explained. Technical File Consultant has gained sufficient knowledge via training, Internal debate, Conferences about actual contents of file and displacement. In short, this team is sufficiently educated to assist and guide with the MDR transition.

  Ø  Technical File Documentation

The new Medical Device Regulation is identifying the forty-seven specific requirements and the content of the primary Technical Documentation. It also has fifteen additional requirements from Post Market Surveillance. This describes the obligation of manufacturers what is needed and why it is needed in the Medical Device Regulation Technical Documentation.

Technical File Consultant documentation insists for an experienced regulatory person and his role in updating the Technical Documentation anytime for Notified Body assessment. The MDD’s Design Dossier concept has been removed from the new EU MDR. The documentations are preparing a Technical File you should have sound knowledge technically to present information on the correct way, some of the core areas are the following.

·       This review is existing documentation in support of meeting the applicable MDR Essential Requirements.
·       It is Identify and evaluate gaps or deficiencies in your new EU MDR.
·       It is determining applicable testing requirements and standards for your device after a Risk Analysis.
·       It is also organized clinical evidence in the form of Clinical Evaluation Report (CER).
·       Preparation of Post Market Surveillance Report (PMS), and derive the conclusion of CER Consultant.
·       Preparation of Post Market Clinical Follow Up Report (PMCF) and derive the conclusion of CER.
·       Review your specimen labeling and Instructions for Use (IFU)and User Manual.
·       Compile Pre-Clinical Verification and Validation documentation.
Location: United States

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