Recent News

Rasmus Funk has joined our R&D team

_MG_0534 webWith a view to the company’s continued development and positive growth within Research and development, we expanded our R&D team with Rasmus Funk.

Rasmus has more than 5 years of experience with medical device product development. He has expert knowledge on single use devices and surgical equipment.

His expertise ranges from the front end requirement mapping and conceptualization through to final production setup.

By helping many projects getting from idea to product Rasmus has gained extensive knowledge on Design for Manufacturability. Especially through cost optimization of products in the competitive single use medical device market.

Rasmus has great experience with minimal invasive instruments and thus also the challenge of manufacturing micromechanical components while ensuring tolerance based robust functionality. He also has great knowledge on cutting edge additive manufacturing and rapid prototyping technologies.

Rasmus has an education in Mechanical Engineering from the Technical University of Denmark with an emphasis on user driven product development and design.

Fast track for Fertility Test for Men

PRESS RELEASE:

MotilityCount and the consultancy company Medicologic have obtained CE approval for SwimCount in just three quarters of a year. This was accomplished through a smooth cooperation between the two companies. Medicologic was clear in its communication on which documentation was required, and MotilityCount delivered it.

In connection with the CE approval and the launch of SwimCount, which is the world’s first reliable home test of men’s sperm quality, Medicologic contributed with their expertise in gathering and writing the documentation required by the British Standards Institution (BSI).

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– Having secured the CE approval, we are now ready to sell SwimCount from our website www.swimcount.com, says CEO Jacob Moellenbach, MotilityCount. – We are also well underway in concluding sales agreements with Danish and British customers.

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Never before – but I will do it again

It takes heart – and a good pair of legs – to ride to Paris on a bike in only 7 days. Medicologic easily agreed to sponsor Stig Jørgensen, CEO of Medicon Valley Alliance, when he joined Team Rynkeby in the now classical charity-ride to raise money for the Child Cancer Foundation.

In 2014, Team Rynkeby donated DKK 36.128 million to the fight against childhood cancer – of which DKK 23.498 million went to the Danish childhood cancer foundation, Børnecancerfonden.

In 2014, Team Rynkeby donated DKK 36.128 million to the fight against childhood cancer – of which DKK 23.498 million went to the Danish childhood cancer foundation, Børnecancerfonden.

In his late fifties, Stig Jørgensen has never before enjoyed cycling as a sport. Now, he has been training twice weekly at spinning since November and with the coming of spring has continued training outdoors. By early July, Stig and his teammates from Rigshospitalet – Team Riget – will be able to ride the approximately 1,200 kilometers from Copenhagen to Paris in just 7 days.

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More manpower to our QA/RA team

With a view to the company’s continued development and positive growth within Regulatory Affairs, we expanded our QA/RA team with Pernille Holm beginning March.

Pernille Holm, QA/RA assistant, Medicologic

Pernille Holm, QA/RA assistant, Medicologic

Pernille Holm started as QA/RA assistant on March 1, 2015.

Pernille has an education in Material Science and Process Technology from the Technical University of Denmark and her main focus was corrosion of electronics and surface technology.

She has more than 10 years of experience with quality control of medical devices. For the last year she worked with quality assurance and process optimization within the construction material industry.

Pernille has worked and done projects in different industries from hearing aids over blades for wind turbines to aero engines. In the construction material industry Pernille worked with optimization of the production in order to reduce energy consumption while maintaining the quality of the product.

Pernille will support our customers in documentation, process mapping, Quality management systems and documents for CE marking of products.

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Outsourcing – a Smooth Operation

Outsourcing is often a cost efficient solution. QMS is no exception. When Otovation decided to outsource their quality management for their entire line of equipment for hearing aids, they chose Medicologic as a partner.

Quality management is essential in the medical device industry as the prerequisite for permission to market products as stated for instance in the EU Medical Device Directive (MDD).

With ever-changing standards and regulatory demands from the health authorities, staying updated can be quite a demanding task for a company’s quality management department. Rather than building and maintaining this expertise in-house, you can hire it from a consultant.

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Invitation til reception

Frank-Petersen-WebnyhedI anledning af Frank Petersens 65 års fødselsdag vil vi gerne invitere til en uformel reception hos Medicologic:

Torsdag den 26.03.15, kl. 15.00 – 17.00

Arne Jacobsens Allé 15-17,
2300 København S

Vi glæder os til at se jer.

Med venlig hilsen
Michael Funder, Medicologic

Praktisk info:
Parkering er mulig overfor i Fields.
I kan benytte indgangen ved nr. 17 (tættest på Metroen)
Vi holder til på 5. sal.

We are strengthening our business

By the end of 2014, Medicologic has strengthened the organisation within QA/RA and Medical Device Development with a view to the company’s continued development and positive growth.

Frank-Petersen-WebnyhedFrank Petersen
Came on board as senior professional consultant QA/RA on December 1, 2014. Frank has more than 40 years’ experience within quality control, quality assurance, development, marketing, support and approval of medical devices. For the last 7 years, he has worked as chief auditor of the Danish accredited agency Presafe (previously DGM).

His many years of experience from both manufacturers of medical devices and accrediting authorities contributes to his extensive knowledge about setting up efficient quality systems, CE marking, and FDA approval of medical devices.

Having been employed with Radiometer and Chempaq, he has more than 15 years of experience with medical devices for in vitro diagnostics.

During his study, and because of his chemistry experience (as laboratory assistant, chemical technician and studies at DTU), he has contributed successfully to development projects, clinical/technical marketing and support, setting up and certifying quality systems, and approval of medical devices.

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Troels Böwadt Arnved-WebnyhedTroels Böwadt Arnved
Started as design engineer consultant on December 1, 2014. Troels has an education in design and innovation at the Technical University of Denmark, and during his study he excelled with his talent for and commitment to product development.

As a part of his studies, he developed a product for digitisation of Denmark’s largest lung clinic, reached the finals in the annual start-up competition Venture Cup, and developed service modules for the start-up company Volt ApS.

Through his thesis, usability came on the agenda at Oticon A/S, where they have now obtained useful tools for development of lower-priced and more user-friendly hearing aids, which meet EN62366 Medical Devices, Application of Usability.

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