News & History

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

New US FDA 510(k) Draft Guidance for Deciding When to Submit a 510(k) for a Change to an Existing Device: Are you currently a manufacturer doing business within medical devices in the USA and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...

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...

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...

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...

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...

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...