Social Zone - Medical Growth House/Aleap

From the capital of medtech in the US; The Twin Cities in Minnesota – the manufacturing company Minnetronix Medical is here in Oslo Science Park. They will share knowledge about what is required to set up production in the US. They will discuss the regulatory domain, the actual process for test production and full-scale and everything this entails.

Please meet Jeff Hird, Business Developement Director-International, and Jim Reed, Vice President Business Development.

Minnetronix Medical was founded in 1996 and are specialists in design, development and manufacturing of medical technology. They specialize in RF Energy, Fluid and Gas Management, Optical Systems and Stim and Wearable devices. Minnetronix has undergone seven successful FDA Quality System Inspection Technique (QSIT) inspections with No Action Indicated (2017, 2016, 2015, 2010, 2008, 2004 and 2001). In a typical year, the QMS is subjected to more than 30 audits by regulators and customers.

Compliance and certifications are always of great importance and the Minnetronix QMS meets these standards:

• ISO 13485:2016 – Medical Devices – Quality Management Systems
• 21 CFR Part 820 – FDA Quality System Regulation (QSR)
• ISO 14971:2012 – Medical Devices – Application of Risk Management
• IEC 62304:2015 – Medical Device Software – Software Lifecycle Processes

Agenda:

14:00  Welcome by Norway Health Tech and Aleap (Anita Moe Larsen and Shane West)

14:10 Meet Minnetronix Medical by Jim Reed and Jeff Hird

@14:45  Questions and wrap-up

16:30 Close

Time for 1:1 meetings – contact Anita for availability.

WELCOME!!