WP07 – Management system for quality & regulatory affairs (QM/RAM)

Objectives

Medical devices and tissue engineering products have to fulfil various legal regulations and standards already during their design phase if those are developed to be marketed inside of the EU. Processes have to be defined and performed conformingly, for the design phase as well as for the later manufacturing, and the conformity of those has to be made evident by standardised means of documentation. The objective of WP07 is to provide in-processly the means and structures which allow best management of resources and processes and which guarantee that the fulfilment of the legal regulations and of the relevant standards can be proven. There shall a Basic Quality Management System and a Master Design Dossier/Master Device History File be  issued for functional materials, Tissue Engineering devices and related Medical Devices which forms as a guideline not only for the developers inside of the HydroZONES projet but for future development projects as well.

It shall serve as a guideline to attain CE-marking and additional market approvals as the 510k premarket approval of the US Food and Drug Administration FDA.

The Basic Quality Management System shall guarantee

  • a standardisation of processes and documentation
  • transparency and comparability of objectives / phases / results / decisions / costs
  • a common understanding of the objectives and the actual status of the project

Workpackage Description

The overall aim of this workpackage is to provide the expertise, instruments and support for quality management and regulatory affairs throughout the HydroZONES project. This will be achieved by the following services and activities:

  • The development of a basic quality management system throughout the project for all consortium members
  • Support for adaption and installation of the quality management system at the consortium member?s organisations by consulting, training, auditing and documentation
  • Support in managing regulatory affairs by consultation, training, auditing and documentation for an efficient fulfilment of regulations by laws and international standards
  • Surveillance of the regulatory framework in respect to revisions, new issues and withdrawals of laws and of international standards and in respect to alterations in their interpretation and application.

The scope of  WP07 is to supply the services listed above to the hydroZONES partners at the running project. The ?mission? of WP07 is to assure full conformity of the development processes and of the conformity of their outcomes by investigation, planning & determination, qualification, verification & validation and comprehensible documentation.

The services and activities supplied by WP07 will be customized to the needs of the organisation of the particular consortium partner to assure an effective and efficient management of the processes which are performed. They will be triggered by the regulations of the laws and of the international standards which are applying and by the individual needs for fulfilling those.

Phase Structure of the Development Process acc. to EN 13485

 

So Quality Management by WP07 has to supply so called SOPs (Standard Operation Procedures) and to train and to validate those to assure that the steps listed above are performed and documented.

And Regulatory Affairs Management by WP07 has to deliver input for those and to follow-up changes and interpretations of the binding laws and the applicable standards.

All activities and documents of QM are composed to form a Quality Management System, which is based on a QM-Manual. All activities and documents of Regulatory Affairs Management are composed to form a Design Dossier/Device History File, which is the basis of the later conformity assessment and market approval.

Premarket use of the STED
Fig. 1: Premarket use of the STED

WP Leader

Health Care Support (HCS)

Dipl.-Ing. Michael Barfuss