Recent News

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.

Contact details

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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Life Science konference 2014 med succes

Torsdag d. 6. november inviterede vi offentlige og private aktører til Life Science konference, hvor deltagerne fik nye perspektiver på udviklingen inden for Life Science og medicobranchen.

Få et indtryk af dagen:

Målet med konferencen var at bringe forskere, producenter og rådgivere sammen og tage nogle emner op, der udfordrede hele branchen. Mere end 100 deltagere tog udfordringen op og fik en interessant og udbytterig dag med relevante indlæg og masser af netværk.

Vi har fået utrolig mange positive tilbagemeldinger på dagen. Det er vi meget glade for og stolte af.

Deltagerne sagde bl.a. om konferencen:
”Alle indlæg var fantastiske”
”Der var gode vinkler og fokus på mere samarbejde”
”Det var en rigtig god måde at have indlæg både fra rådgivningssiden og fra industrisiden”
”Konferencen gav stor mulighed for at skabe netværk”
”Vi blev præsenteret for nye forretningskoncepter, nye vinkler på rådgivning og fik inspiration til nye metoder”
”Det her er nytænkning inden for medicondustrien”

Se uddrag af indlæg og download præsentationer.

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Invitation til Life Science konference

Få nye perspektiver på udviklingen inden for Life Science og medicobranchen, når Medicologic inviterer offentlige og private aktører til Life Science konference.

Please note that the conference will be held in Danish.

LifeScienceKonference2014

Vi har inviteret spændende talere inden for både forskning, udvikling og rådgivning. Vi kommer også omkring erfaringer og resultater af den industripolitiske indsats for fastholdelse af den danske konkurrenceposition inden for Life Science.

Markedet stiller højere krav til medicobranchen, hvor fokus på patienternes sikkerhed, livskvalitet og optimale behandlingsmetoder øges. Life Science virksomheder i Danmark kan være med til at udvikle løsninger der kan leve op til markedets forventninger, krav og udfordringer samt skabe vækst og velfærd.

Se det fulde program og spændende talere

Tid og sted
Torsdag den 6. november 2014
kl. 9.00-13.00, efterfulgt af en let frokost
Arne Jacobsen Allé 13, Ørestad City, 2300 København S

Tilmelding
Tilmelding sker efter først til mølle princippet
Deltagelse er gratis

Lars Bo Andersen, lba@medicologic.com eller på telefon 48 24 51 13

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.

IMG_3686

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