Full CV send by mail per request
Gert Andersen 
Knows how to bring Medical Devices to the market, because I have done it before. Proven track record of taking a Medical Device start up to ISO 13485 certification and CE mark. Has hands on Regulatory and Clinical experience in all aspects of setting up the QMS and bringing the product through Design Controls to Market Access. Trained auditor MDR 2017, IVDR 2017 and ISO 13485:2016.
Before that +10 years of experience and a proven track record as a Sales and Marketing Executive in the Medical Device Business.
I have experience with success and pitfalls in building Start Up’s from scratch. I have in depth knowledge and experience in the specific art of Medical Marketing and have conducted several Product Launches.
I have widespread legal experience developed by working with Patents, Licence agreements, Royalty agreements and distributor agreements.
I have excellent intercultural and interpersonal skills demonstrated by successful business achievements in Europe, Asia, Latin America and US. As an engineer and with a background in R&D I understand the full spectrum of a company in the Medical Industry.
Specialties: Regulatory Processes, Medical Marketing, Medical Sales, Licenses, Trademarks, Patents, Product Development, Clinical Studies.
EMPLOYMENT
2007 to date
Owner. Transmedical Alliance Consulting – Owner
Customers include:
- Radiometer (Regulatory Consultant)
- Leo Pharma (Regulatory Consultant)
- Wavecare (Regulatory Consultant)
- Faaborg Pharma (Regulatory Consultant)
- RD-Support (Regulatory Consultant)
- Optoceutics (Regulatory Consultant)
- Measurelet (Regulatory Consultant)
- Snapform (Regulatory Consultant)
- Antia Therapeutics AG (CEO)
- Soltech Aps (BD/RA/QA)
- EmboCoH project (Project Manager)
- Millimed (BD consulting)
Antia Therapeutics AG
Responsibilities include – all hands on:
- Liaison with Investor and Scientific Founders
- Member of Board
- Project Manager
- Research Project
- Product Development
- Bench Testing/Feasibility Testing/Animal Testing
- Building the QMS (ISO 13485 certification achieved)
- Quality Manual
- SOP’s
- Quality Forms
- Quality Records
- Design History File
- Design Plan
- Design Reviews
- Design Input
- Design Output
- Design Verification
- Biocompatibility Studies
- Design Validation
- Three Clinical Studies
- Design Transfer
- Device Master Record
- Risk Management File
- Specifications
- Labels (Including IFU)
- Manufacturing
- Product
- Packaging
- QC
- Device History Record
- Technical File (CE mark achieved)
- IP management
- Supply chain
- Supplyer selection and evaluation
- Supplyer contracts
- Supplier audits
- Distribution
- Distribution selection and evaluation
- Distributor contracts
- Distributor audits
THERAPEUTIC EXPERIENCE
| Year | Phase | Indication | Countries Sites/ patients | Role | |
| 2018 – | Pivotal study CE Mark | Neuroradiology – class III device | Europe | Sponsor | Project Management Sponsor |
| 2018 – | RES | Vascular device for occlusion of hypervascular peripheral lesions | Europe | Sponsor | Project Management Sponsor |
| 2018 – | PMS | Vascular device for occlusion of hypervascular peripheral lesions | Europe | Sponsor | Project Management Sponsor |
| 2014-2018 | PMS | Vascular device for occlusion of hypervascular peripheral lesions | Europe/US/Asia | Sponsor | Project Management Sponsor |
FIM – First-in-man
PIL – Pilot
RES – Regulatory study
RES US – Regulatory study, US
PMS – Post-market study
Languages:
- Danish: mother tongue
- English: fluent
- German: high level conversational
- French: Introduction level
Engblommevej 47, DK-2400 Copenhagen Denmark, Phone +45 23600650
Date of Birth : April 8, 1960; Married, 2 children
Skype ID: gert.0804
transmedicalalliance.com 