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Choose the auditor that is right for you

In choosing your auditor, trust is of the essence, and the conviction that such audits add value to your company.

The advantage of utilizing your own auditors is, of course, their in-depth knowledge of the company and hence their ability to examine areas and contexts that have shown a need for review and possible improvement.

The risk is the inability to review one’s own area of work or one’s immediate superiors; not seeing the forest for the trees, so to speak; and fearing for the advancement of one’s own career when pointing out the boss’ failings to comply with specified procedures.

Reading glasses with light frame over the open bookBy utilizing certified, external auditors, you will be able to draw on their knowledge of other ways to perform the procedures, so the process of reviewing also yields suggestions for possible optimizations. It is also possible to have the same external auditor review your company on a regular basis, yielding a deeper level of insight and hence a more thorough audit.

Unfortunately, the added value from such “same old” auditors may also decrease over time, as the recurring reviews can become a matter of habit and may cause the auditor to always look in the same places and to become apprehensive about addressing non-conformances.

So whichever type you choose, it will always be recommendable to make a change once in a while: Fresh eyes often spot new issues from new angles.

Apart from the need for fresh eyes and independence, a company may from time to time need additional auditor resources just to comply with the audit plan for the year. Medicologic’s auditors will be able to help the company out. Our auditors are available at short notice and ready for audit assignments in Denmark and abroad

Medicologic can help you through the audit process.
Call us for a talk.

Asger Dahlgaard
Program Manager
Direct (+45) 22 47 41 06
ad@medicologic.com

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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