Recent News

Simulations and analyses save time and money

With simulations and analyses of plastic parts you can achieve significant cost savings and important knowledge about your future production, or a production that you would like to optimise.

One way to analyse plastic parts and optimise them for production is to use flow simulation – before you ask the toolmaker to work on expensive moulds. High costs can be saved by using 3D models to change the parts, and avoid using the final moulds for that.

At Medicologic, simulations and analyses are a part of our development process. But flow simulations are also useful if you have ended up with a production batch that did not quite turn out as intended. In those cases, we analyse the part and suggest how it can be changed and optimised. Flow simulations and analyses can for instance pinpoint structural weaknesses, convergence difficulties, strength problems, risk of warped plastic parts, possibilities of materials consumption optimisation, etc.

Flow simulations and analysis Claus Erikslev Jensen (l) and Mads Madsen (r) are experienced developers in the Product Development team at Medicologic performing simulations and analysis.

We have many years of experience in simulation and analysis, and a dedicated team is available for the execution and to provide guidance. Our team with Mads and Claus are experienced developers at Medicologic. Claus’s experience includes 8 years in the hearing aid industry, where he was responsible for the use of flow analyses in the daily operation.

The Danish companies Radiometer, Coloplast and GN Resound are among the customers who have benefited from our assistance in production optimisation.

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

Get on top of your project’s budget and schedule before you start

By carrying out a preliminary project, you will get an overview of the schedule and budget in a major project.

The purpose of a preliminary project is to obtain an understanding of the process and the economic viability of following through with the idea or the concept until you have the final product. A preliminary project will typically give you an overview of non-recurring costs and the final estimated product price, which are important parameters to estimate the total project budget.

The result is a well prepared base which you can use to develop business cases and attractinvestors.

_MG_2334 web For one of our customers, we carried out a preliminary project to assess the profitability of developing a customised container for their own production. A container that was required for the production, but could not be procured anymore.

Based on the result of our preliminary project, the customer was able to calculate whether it would be worthwhile to proceed and make further investments in the development and production of the new container.

At Medicologic, we carry out preliminary projects continuously. For instance:
– The first iteration of the product design and functionality (product specification)
– The best mix of potential subcontractors
– Test plan (EMC, shelf life, toxicity, biocompatibility, product verification, process validation)
– Cost estimates from subcontractors and of R&D, approval and QA
– Project schedule

Would you be interested in an offer for a preliminary project?

Please contact
Martin Thomsen
Team Manager, Product Development
mt@medicologic.com
Phone: +45 2247 7212

Choosing an external auditor means new insight and feedback on your processes

Medicologic has recently performed a series of audits at customers in Denmark, Central Europe and as far away as Mexico. These audits were internal audits at the customer’s premises and we were asked to perform the audits as the customers needed a new set of eyes looking at their internal processes and the interfaces to their suppliers.

_MG_1732 web Based on the audit expertise of Medicologic the customers have all gained new insight into their processes. In some cases the audit revealed non-conformances and opportunities for improvement.

In many cases the audit confirmed a well running quality system aligned with the business need. Feedback such as the above is important for the further development of the companies’ quality assurance programs.

We were primarily chosen as auditors due to our long term practical experience with all aspects of a quality system from senior positions in the medical device industry but also from our ability to act timely on the customers’ need for an auditor.

The feedback on our approach to auditing which was seen as “somewhat different” to what our customers had experienced before was extremely positive. This positive feedback was mainly a result of our ability to create a constructive and inspiring dialogue with the staff being audited and our ability to come up with relevant suggestions and advice throughout the audit.

At Medicologic we strive to ensure that our customers always get a positive and constructive audit which adds value in terms of recommendation, but also acknowledges if the internal processes are well integrated in all aspects of the business.

Medicologic can help you with internal audits and supplier audits within ISO9001, ISO13485, ISO 14001 QSR and other medical device regulatory requirements.

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

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Per Maegaard is now certified as Lead Auditor

pmaeAs of March 2014 our audit team has been expanded. Per Maegaard is now certified as Lead Auditor and Per is able to perform ISO 14001 audits in addition to the audits of medical device quality systems.

Per Maegaard
Senior Quality Consultant
B.Sc. Int. Trade, Business & law
pma@medicologic.com
Direct (+45) 22 47 09 52

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