News and history
Over the years a lot has happened – many interesting project, excellent clients, and skilled people.
Our concept and services have changed – but our history has not.
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 the many obstacles and find a successful way to move forward – you...
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New US FDA 510(k) Draft Guidance for Deciding When to Submit a 510(k) for a Change to an Existing Device: Are you currently a manufacturer doing business within medical devices in the USA and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 your product cleared by the FDA as a 510(k)? Then you need to be aware of...
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 team and interact with customers to solve hands-on QA/RA assignments....
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 almost 20 years of experience within Regulatory Affairs, working for a...
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 political agreement. It is still subject to approval by the Council's...
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 extensive research project in France for a leading client in the health...
Know-how, skills and mindset
Medicologic is a leading Danish design and engineering company specializing in innovation, product development, usability, design for manufacturing and quality assurance within the medical device sector.
Through our device consulting services – made possible by our highly qualified, skilled and innovative consultants – we can assist you in decreasing your product development cycle times, reducing development costs and developing robust devices designed for manufacturing – obviously while observing all relevant regulatory and legal requirements.
Based on our proven technological know-how, process management skills, innovative mind-set and ability to plan and execute highly complex development projects, we strive to be the preferred partner and consultant to our customers. Working with us you will find that we are innovative, enterprising, accessible and professional – and that we really enjoy working on challenging projects.
For almost 20 years we have served our customers and today we are proud to count some of Denmark’s leading medico companies among our clients.