CV

Full CV send by mail per request

gert@transmedicalalliance.com

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:

  • 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 SponsorProject 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

gert@transmedicalalliance.com

Skype ID: gert.0804

        

                                           

          


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