Projects and references to talk about ...
Looking for a consulting partner You are interested in the kind and size of the realized or started consulting projects of consulting & more. Knowing this some projects will be introduced shortly in the following. Please note that all customers mentioned below agreed to the publication by consulting & more:
AdnaGen AG, Hannover-Langenhagen:
Update of the existing Quality Management Systems to the actual standard ISO 13485, Implementation of a performance measurement system, Developing of a procedure for Process Risk Management and Training of the internal Auditors acc. to ISO 19011:2002.
AESKU.DIAGNOSTICS GmbH, Wendelsheim:
Update of the existing Quality Management Systems to the actual standard ISO 13485 and support in creating 510(k) Submissions of Diagnostic Kits.
DiaSorin Deutschland GmbH, Dietzenbach:
Realization of the requirements of ISO 14971:2000 on Risk Management for diagnostic systems, support in creating Validation Plans and support in creating 510(k) Submissions of Diagnostic Kits.
BIT Analytical Instruments GmbH, Schwalbach:
Training on the process approach to Quality Management according to the actual standard ISO 13485, analysis and graphical documentation of the main processes together with the management team and workshop for developing a procedure for Risk Management in processes as base for Process Validation.
MAT Membrane Adsorption Technologies GmbH & Co KG, Obernburg:
Realization of the requirements of ISO 14971 on Risk Management for medical devices, development of a procedure for Process Risk Management on the base of ISO 14971, implementation of a Quality Management System acc. to ISO 13485 in the framework of the groups Quality Manual.
Paul Marienfeld GmbH & Co.KG, Lauda-Königshofen:
Realization of Risk Management for Medical Devices and IvD Devices acc. to ISO 14971:2000 and support creating the Technical Product File and Instruction for Use of In Vitro Diagnostic Medical Devices.
Webers Laborbedarf GmbH, Bottrop:
Training of sales and service personnel acc. to §31 and the "Security Officer" acc. to §30 MPG (German national law) and implementation of a Quality Management System acc. to ISO 9001 in diagnostic trade and service business.
SC – Sanguis Counting Kontrollblutherstellungs- und Vertriebs GmbH
Transfer to a process oriented QA-System according to ISO 13485, Training of the medical product conultants according to §31 MPG, External security consultant according to §30 MPG
Metecon GmbH
Sometimes the clinical assessment is easier with knowledgeable, writing support. Even a development documentation or verification can sometimes benefit from external support.
With these few consulting projects the consulting & more services should be well described. Please understand that not all projects could be publicized like this because it is not every time in the interest of a customer to be named.
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