Recent News

Our quality assurance program? Sure, it’s over there on the shelf!

The effectiveness of a quality assurance program is highly dependent on regular optimization. In any regulated industry subject to rules of authority and certification, some form of quality assurance is a necessity. But such a system has a tendency to grow once it’s implemented, because “Oh, we need to put this in there, we need a procedure for that, too!” This does not increase effectiveness – quite the contrary, in fact.

Shelf with Folders


How do you get your quality assurance program off the shelf and into your business?

For effectiveness, it is important that only the right things are described and that management has prudently determined how to adapt the system to the organization, instead of the other way around. Of course, minimum regulatory requirements and certifications must be met. For the regular system review, many regulated firms and their subcontractors utilize internal audits, performed by either the company’s own auditors or certified, external auditors.

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Bliv QMS Auditor

Få papir på din viden om ISO 13485 standarden og lovgivningen om medicinsk udstyr

Den 18.-20. marts 2014 inviterer Medicoindustrien til Medical Device ISO 13485 / QMS auditor kursus.

Man får viden og værktøjer, så man kan auditere i ISO 13485 standarden og den relaterede lovgivning.
Kurset har 3 hovedelementer, som er lovgivning om medicinsk udstyr, ISO 13485 og audit.
Gennem praktiske øvelser bliver der mulighed for at prøve at auditere efter standarden.

QA-RA-kursus

På kurset underviser bl.a. Senior Quality Consultant, Per Maegaard, Medicologic A/S

Læs hele programmet og tilmeld dig her.

Hvis du har spørgsmål omkring QA/RA, så kontakt

Asger Dahlgaard, Program Manager

Direct (+45) 22 47 41 06
ad@medicologic.com

End-to end-consulting at Medico Bazar 2014

January 14th Medicologic exhibited at the Medico Bazar at DTU. Medico Bazar is an annual exhibition arranged by Medico Innovation unveiling some of the newest developments and research within medtech. It is the aim of Medico Bazar to encourage knowledge sharing and connect people and companies with interest in the medical device field.
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Fokusér på innovation og patientsikkerhed

De fælleseuropæiske medicotekniske godkendelsesregler er under revision. Foreløbig er der brugt mere end et år fra EU-Kommissionens forslag blev fremsat til at få sagen gennem Europaparlamentet.

Efter at Europaparlamentet ultimo oktober har vedtaget revisioner til EU-Kommisionens forslag skal embedsmænd, politikere og interesseorganisationer i den kommende tid arbejde på at finde frem til en lovtekst, som kan godkendes i det samlede EU-system.

Kommentar af seniorkonsulent, Kirsten Rønø, Medicologic A/S

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Minimizing risks and adding value with usability

When working with development of medical devices, safety is crucial. Modern technology and improved product features are very important factors for the safe use of the final product. But how do you handle the human factor?

By integrating usability in the product development process you minimize the risk of incorrect use of the final product. Usability testing, analysis and involvement of users in the development process can help to identify potential risks in the early development of a new product.

Usability in product development Usability also increases your product’s market value due to the improved ease of use. And at the same time you meet the legal usability requirements. Both FDA and European authorities are raising the demands for usability as part of the final product approval. EN62366 already describes this.

At Medicologic we integrate usability into our solutions. We advise on and perform usability studies, usability testing, usability evaluation and UI design. Recently, we upgraded our knowledge through a course with Nick Bradley, BERGO.

Want to know more?

Martin Thomsen
Senior Industrial Designer, M.Sc. Engineering

Direct (+45) 22 47 72 12
mt@medicologic.com

2 hours Of Medica 2013 in 30 seconds

We’ve just returned from Düsseldorf and Medica 2013 with a lot of new relations, new knowledge and inspiration! We can’t wait to follow up on all these contacts.
Check out this time lapse video of 2 typical hours from our stand.

Best regards, Medicologic

Are you our new Product Developer?

Product Developer

Do you want to make a difference in other people’s lives, through mechanical solutions?

At Medicologic A/S we are striving to become the preferred partner within the Medical Device Industry. To reach this goal we are on the look for sharp brains to join our dynamic team of developers. Your main tasks will cover project management, construction and 3D modeling. Projects at Medicologic differ in size and you should therefore be able to adapt to project teams as well as manage small assignments on your own.
Based in Hillerød, you will handle different projects simultaneously and be in charge of contact to clients, collaborators and sub suppliers.

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Medica-slide

Meet us at Medica 2013 – Düsseldorf, 20-23 Nov. 2013

MEDICA is the world‘s largest Life Science and MedTech marketplace and meeting place for people working within the medical industry. This year Medicologic is part of the shared Danish stand in hall 16 stand D-41.

Free tickets for MEDICA

We offer free tickets for MEDICA. All you need to do is send a mail to Lars Bo Andersen, lba@medicologic.com specifying how many tickets (voucher codes) you need.

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Are you ready for the new UDI legislation?

FDA has approved UDI legislation – Europe is on its way
As part of the steadily increasing requirements for medical devices, the FDA has approved a new law that provides specific requirements for a unique marking of medical devices – UDI, which stands for Unique Device Identification.
The new system will ensure that reporting of serious incidents are more precise, while making it easier for authorities and users to gather and analyze data from the market.

What does it mean to your business?
The legislation will enter into force on 24 September 2014 and will apply to all medical devices sold in the United States. A similar requirement is expected to be adopted in Europe. To many manufacturers of medical equipment it means modified workflows, new needs for data handling and increased costs.

When will the legislation be relevant to you?

UDI-timeline-1

Getting Started
Medicologic, in collaboration with the American software house PTC offers coaching and counseling as well as an out-of-the box software solution for handling of the new requirements. Our specialist consultants will help in the process from needs analysis to implementation and training.

Want to know more?
Asger Dahlgaard
Program Manager, B.Sc Engineering

Direct (+45) 22 47 41 06
ad@medicologic.com