Medical Devices

Nuclear

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Sector

Medical Devices

Working towards technical development in medicine

agap2 works in the following areas :

Medical devices Class I, IIa, IIb and III
Implantable medical devices
Active imaging implantable medical devices
In Vitro diagnostic medical devices
Imaging

Areas of expertise

Research & Development : Mechanical design, DHF, DMR, Prototyping, Writing the specifications, Use Ability, Signal processing
Clinical studies : : ARC (clinical research associate), CMM (cellular and molecular medicine), CRO (contract research organisation)
Regulatory affairs : Regulatory affairs manager, Writing technical files in preparation for CE marking
Project management : Transversal project management
Quality : Quality Assurance System, Operational Quality Assurance product, Supplier Quality Assurance, Quality Control, Product Quality
Engineering and process engineering : Process optimisation, Process validation, Equipment and utility qualification, New works, HSE, Preventive and/or curative maintenance
Supply Chain Management : Procurement, Line method engineer, Serialisation, Packaging
Post Market Surveillance : Pharmacovigilance, Materials vigilance, Cosmetovigilance

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Project 1

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SamanTree Medical
Design of an innovative scanner for cancer surgery

Context : The Histolog™ Scanner was developed by a Swiss start-up and can be used in the operating theatre to analyse a tumour immediately and determine if it has been removed completely. Thanks to this procedure, the start-up estimates that re-operations can be reduced by up to 90%.

agap2 expertise : Aurèle works on the design, development and industrialisation of the disposable optical interface of the Histolog™ Scanner.