Categorized as: Management consulting

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 NielsenGert has almost 20 years of experience within Regulatory Affairs, working for a number of med-tech companies including Ambu, Radiometer and GE Medical Systems. Lately, he worked four and a half years for ultrasound equipment manufacturer BK Medical. At Medicologic Gert’s primary responsibility will be to support clients by developing classification and mapping of regulatory strategies, creating technical files and design history files as well as preparation and submissions of FDA 510(k) and international applications. Gert will also be working as a QP (Qualified Person) for selected clients.

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We are moving to new offices in Ørestaden

1st of October 2014, we’ll be moving to our new modern office space in Ørestaden with plenty of room for both development and growth.

We have in recent years experienced a significant increase in demand and positive growth within our competences: End-to-End Medical Device Consulting, Research & Development, Quality Assurance and Regulatory Affairs.

We have a clear ambition for further growth and a desire to expand our network of customers and partners. With the new office we will have plenty of room for both development and growth.

We look forward to move into our new office, which is located in an international environment in Ørestaden and centrally located for the metropolitan area, Southern Sweden, train, metro, the highway network and Copenhagen airport.

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Our new address is:

Medicologic A/S
Arne Jacobsens Alle 15-17
2300 København S

You can still contact us using the same telephone numbers and emails.

We look forward to inviting you to our new office.

Best regards,
Medicologic

Continuous training is keeping us a step ahead

Medicologic is an innovative company believing that expertise builds confidence with the customers. In order to develop our expertise and add value to the projects we manage, we believe that continuous training is a must.

Recently all Medicologic employees took part in a tailored training program on business-oriented project management and agile project management. Methods that we feel certain are key to well-driven and successful projects.

Training

The program provided our team with powerful and innovative frameworks and tools to help customers bring their products to the market successfully. Tools that strengthen our consultants in keeping the right balance of time, product features and resources needed at any given time of the project. Through agile project management we can secure a high quality end product by keeping track of milestones and always match the expectations of our clients.

At Medicologic we have experienced that continuous training and streamlining of our tools and processes brings us a step ahead and we feel confident that we will continuously add value to our customers’ projects by using the know-how derived from ongoing training in our daily work with our customers.

Contact
Martin Thomsen
Teamleder, Product Development
mt@medicologic.com
Phone: +45 22 47 72 12

Japanese Research Institute chooses Medicologic
as Business Process Management advisor

Medicologic’s Center of Excellence, Quality Assurance was chosen as the only Scandinavian Center by Nomura Research Institute (NRI) – a leading systems integration and management consulting firm based in Tokyo, Japan – to take part in a European research.

The main focus of this research was on how global companies in Europe handle business processes, as well as process automation and optimization.

IMG_2165-webApril 11th 2014 Medicologic A/S hosted a Japanese delegation at our location in Hillerød.

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