News & History
Our concept and services have changed – but our history has not.
Senior RA Expert DVM, PhD, MBA (ID1001)
Human Factors Engineering Specialist
< Previous consultant< Go to overviewHuman Factors Engineering and UsabilityNext consultant >Human Factors Engineering SpecialistMSc. Design and InnovationAvailable for:...
Lesley Gjelstrup Kristensen joins Medicologic as Senior Consultant, Regulatory Affairs & Quality Management
As of May 2019, Medicologic has strengthened the organization within the Regulatory Affairs field to meet the continuous company development and positive growth. Lesley Gjelstrup Kristensen came on...
Welcome to our RA blog – RA-Update.com
It is a pleasure to introduce our new RA blog. Being your global partner within RA/QA we would like to share our new RA blog with everybody who has an interest in what is going on in the complex...
Adding further Design Controls and Project Management experience to our Team – welcome to Søren Bundgaard
As part of a continued focus on delivering high-value RA/QA consulting for medical device companies, Medicologic has hired Søren Bundgaard in the role as Senior Consultant, Design Controls & Project...
Additional 30 years of experience to our Quality Management & Regulatory Affairs Team – welcome to Eva Steinick
As part of a continued focus on delivering high-value RA/QA consulting for medical device companies, Medicologic has hired Eva Steinick in the role as Senior Quality Management & Regulatory Affairs...
Strengthening our capabilities within commercial business development – agreement with Vibeke Harbud
Having Vibeke onboard Medicologic now offer services such as business case development, competitor and market analysis including user feasibility and key opinion leaders interviews leading to...
We are looking for a Senior Regulatory Affairs Specialist
With a strong pipeline of challenging projects we are seeking a Senior Regulatory Affairs Specialist to join our QA/RA team in Copenhagen. Reporting to the Team Manager you will be part of our QA/RA...
We are looking for passionate QA/RA people
With a strong pipeline of challenging projects we are seeking two passionate QA/RA people to join our QA/RA team in Copenhagen. Reporting to the Team Manager you will be part of our QA/RA team and...
New QA cooperation reinforces Medicologic capabilities – agreement with QA expert Stig Larsson
As a result of increasing demands for high-value QA services, Medicologic has entered an agreement with Stig Larsson – renowned as a leading QA expert in the medical device industry. The QA...
Randi Hauerberg becomes partner in Medicologic A/S
After one year of employment Randi Hauerberg becomes partner in Medicologic A/S. Randi Hauerberg came on board as Principal Advisor/Team Lead on March 1, 2016 and has since then contributed with her...
Medicologic is beefing up on combination product expertise
Complete combination product team in place with new associate The development of combination products is speeding up, and many pharmaceutical companies view the “diagnostic or therapeutic products...
Strong insights and human factors design result in brilliant product
Immunotherapy: Danish biotech company CytoVac A/S benefits from simple Medicologic innovation. [divider margintop="5"]Finding the right solution can be a tricky process. However, once you overcome...
Proper FDA clearance is essential for avoiding regulatory delays and expenses
New US FDA 510(k) Draft Guidance for Deciding When to Submit a 510(k) for a Change to an Existing Device: Are you currently a manufacturer doing business within medical devices in the USA and is...
We are looking for a passionate Senior QA/RA Consultant
With a strong pipeline of challenging projects we are seeking a passionate Senior QA/RA Consultant to join our QA/RA team in Copenhagen. Reporting to the Team Manager you will be part of our QA/RA...
We strengthen Regulatory/QA capabilities by hiring Gert Nielsen
As part of a continued focus on delivering high-value RA/QA consulting for medical device companies, Medicologic has hired Gert Nielsen in the role as Senior Regulatory Affairs Consultant. Gert has...
Medical devices: deal reached on new EU rules
On 25 May 2016, the EU agreed new rules on medical devices and in vitro diagnostic medical devices. The Netherlands presidency of the Council and representatives of the European Parliament reached a...
R&D work with Medicologic in France could have tax benefits
Medicologic has received the CIR (credit d’impôt recherche) approval by the French Ministry of Research and Higher Education as one of very few Scandinavian med-tech consultancies. Following an...
Bliv opdateret på de nye regulatoriske krav inden for medicinsk udstyr
Fredag d. 29/4 kl. 8.30 afholder Medicologic og SAXOCON et miniseminar, hvor du bliver opdateret med det seneste nye inden for såvel Medical Device Direktivet, biologisk sikkerhedsvurdering samt CE...
ISO 13485:2016 is here – are you ready for it?
One of the most common and internationally recognized standards for medical device quality management has been revised for the first time since 2003. We have pinpointed some of the changes and what...
Randi Hauerberg has joined Medicologic as Principal Advisor – Regulatory Affairs
As of March 2016, Medicologic has strengthened the organization within Regulatory Affairs and Medical Device Development with a view to the company’s continued development and positive growth. Randi...
Know-how, skills and mindset
At Medicologic we know all about the challenges of finding talent and the right skill-sets for the tasks.
Medicologic was founded in 2009 by the present CEO Michael Funder, and through more than 20 years we have strived to find the greatest talent and the most skilled specialists for the medical device industry.
Our goal is to create the best scenarios for our clients, and combine our talent and specialists with the goals and budgets at hand.
We strive for customer-service excellence – and a part of this is providing a service, that gives our clients full flexibility to pull on our various ressources on any given time.
The expectations in the medical device market are high with increasing focus on patient safety and treatment methods.
Our team of dedicated freelance consultants and specialists help you develop solutions that meet the expectations, requirements and challenges in the medtech and pharma markets.
Contact
Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
Email: contact@medicologic.com

Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com

Lars Bo Andersen
CFO / Administration
(+45) 48 24 51 13
lba@medicologic.com