Frank Grube Email & Phone Number

Biol, Auvergne-Rhône-Alpes, FR

Grenoble Area, France

Systems+Quality+Engineering= Operational Consulting for Safety Critical & Medical device Systems is my PassionLet's make a difference!Let's go "beneath the surface"...

Paris Area, France

Helping Medical Device and In-vitro companies to improve their Design Control processes with the consulting team of AxDaNe and the PLM-tools of DASSAULT systems:- 3DS License To Cure - Certified for Customization Fundamentals R2016x- Reqtify

Grenoble Area, France

Creating "Internet of Things" THINGS that make a difference:- for the Industrie 4.0 - for some of the most creative start-ups of the momentwith the leading edge BLE 4.2 Bluetooth stack of Alpwise.

• Definition of technology and strategic product roadmaps for the Business Unit
• Expert support for project compliance with CE marking and FDA 510k

• Definition of the System- and Software-Architecture for the next generation of Infusion devices and Clinical Protocols
• Technical support of Regulatory and Quality Department for 510k file
• Successfully passed FDA inspection in January 2015

• Definition and implementation of an IEC 62304 -conform SW development process for Medical Devices
• Techncial expert for subcontractor audits (IEC 13485)

• Project management of the product development of a Class IIb Medical Device from userrequirements definition until production transfer
• DHF and DMR management compliant for CE and 510k marking