Categorized as: QMS – Quality Management System

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

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