University of Gloucestershire

Universität Liechtenstein

HTL Rankweil

Co-Founder at Blue Broccoli GmbH

Consultant for Medical Devices:
- Quality/Regulatory Management
- Product Design and Development
- Asia Sourcing and Manufacturing
- Asian Market Entry Strategy

○ Recent projects: Lead project for medical AI Startup to develop and implement a quality management System until initial ISO and CE certification.
Successfully identified and approached Taiwanese distributor for a Swiss surgical medical device company and guided through the TFDA approval process

Blue Broccoli GmbH

Co-Founder

- Business Development US market
- Distributor Management, Distribution Contracts
○  Projects: Launched digital dentistry systems sales in the US (complex system sales including CNC, CAM/CAM integration, materials and linking parts). Reached sales target of 1M within first year.

Biodenta

Sales Manager North America

- Dental Implant System
- Digital Dentistry System
○ Projects: Developed Stock components, CNC Holders, CAD Design Integrations, CAM Integrations

R&D Manager

- General Manager of MPT (Biodenta's manufacturing entity)
- Lead Product Development, Logistics, Production, Process Engineering, and Quality Departments (55 persons)
○ Projects: Planned and executed buildup of new CNC workshop facility. Reduced factory lead times by 50% through streamlining manufacturing and inspection process. Implemented paperless production system (MES).

Mediprecision Technologly Corporation

General Manager

- Quality and Regulatory Affairs (Biodenta Group)
- Lead Global Quality and Regulatory Team (5 persons)
○ Projects: Build up Global Quality Management System from scratch. Carried out initial ISO and medical device class IIb CE certification in less than a year. Submit and cleared 11 implant or dental CAD/CAM US FDA 510(k)s.

Quality and Regulatory Manager

- Product Management for Branded Blood Pressure Monitors
- Project Management for OEM Key accounts: Fever Thermometer, Flexible Heating
○ Projects: Developed and launched home use medical devices with factory and R&D Team in Shenzhen, China. Presented product and solutions in front of European Society of Hypertension Consensus meeting and European Distributor meetings

Microlife AG

Product Manager

- Quality and Regulatory Affairs (incl. audits and approvals)
- Technical Project Management
- Clinical Validations and Field Tests
○ Projects: Lead Clinical Validations with Key Opinion Leaders in the Hypertension field. Set up and overlooked processes of internal clinical validations for blood pressure monitors and fever thermometers.
Successfully handled audits from key customers and notified body at our factory in Shenzhen, China

David Eiler