About us.
Founding team
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Niels Erik Holm
Co-founder and CEO, Niels Erik Holm, is the inventor of several multi million dollar products (Insulin Infusion Set, NovoLet, Vivostat System) and are the inventor of more that 20 worldwide patent
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John Hørby
Co-founder, John Hørby, MD, Consultant in Breast Surgery, is the co-inventor of two medical devises for single use (Naso-Fix [danish], Drain-Fix [danish])
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Bo Jesper Hansen
Co-founder and Chairman of the Board, Bo Jesper Hansen, MD Phd, has several years of entrepreneurial and management experience within the pharmaceutical industry.
Operational team
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Niels Erik Holm
Co-founder and CEO, Niels Erik Holm, is the inventor of several multi-million dollar products (Insulin Infusion Set, NovoLet, Vivostat System) and is the inventor of more than 20 worldwide patents.
neh@innoventamedica.com
+45 2622 1962
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Ulla Tedaldi
Production & Quality, Marketing, Administration
Ulla has been the QA/QC Manager since 2007. She is the primary responsible person for the companies QMS system and CE mark in collaboration with the Notified Bodies. Ulla is also responsible for Sales and ordering, warehouse and distribution of devices including sterile devices. Additionally, Ulla participates in produce design and development, distributor and importer agreements and monitoring Clinical studies.
ut@innoventamedica.com
+45 4063 6126
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Marlene Sejer Jacobsen
Manufacturing & Packaging
Marlene has been the Manufacturing Assistant since 2016. Marlene works primarily wth Seroma Set in the clean room.
External Consultants
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Henrik Kvistgaard
Henrik Kvistgaard, Quality Assurance Consultant
Henrik Kvistgaard has been working with Quality Assurance within Medical Devices and In-Vitro Diagnostic companies since 1992 and has since 1999 also worked with Regulatory Affairs in In-Vitro Diagnostic and Medical Devices. He is an external contractor for Innoventa Medica ApS. Henrik has performed over 100 company audits, over 75 technical files for all device classes and over 40 FDA mock-inspections.
hkv@medecon.dk
+45 20460331
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Laura Rossing
Laura Irwin Rossing, Regulatory Affairs Contractor, External
Laura has been working with Regulatory Affairs in Medical Devices since 2013 and is an external contractor working with LECIGON products CE marking and Post-marketing activites. She has worked with Technical files all classes of Medical Devices.
laura@raqa.dk
Tlf: 40129969
Quality.
For Innoventa Medica, quality is a key word and we are constantly working to maintain and improve quality.
We are certified by Eurofins in relation to the Quality Management System standard 13485:2016 and Medical Device Directive 93/42/EEC.