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Proper FDA clearance is essential for avoiding regulatory delays and expenses

New US FDA 510(k) Draft Guidance for Deciding When to Submit a 510(k) for a Change to an Existing Device:

udklipAre you currently a manufacturer doing business within medical devices in the USA and is your product cleared by the FDA as a 510(k)?

Then you need to be aware of that the FDA on August 8 has issued an updated draft guidance for manufacturers deciding whether to submit a new 510(k) when making modifications to medical devices already in the market.

Furthermore, a complementary draft guidance on software modifications was also issued.

The updated FDA guidance retains the basic format and content of the original guidance issued by the FDA in 1997, but with updates for clarity. FDA also drew from existing policy and related guidance in updating the draft guidance document, including:

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We strengthen Regulatory/QA capabilities by hiring Gert Nielsen

As part of a continued focus on delivering high-value RA/QA consulting for medical device companies, Medicologic has hired Gert Nielsen in the role as Senior Regulatory Affairs Consultant.

Gert NielsenGert has almost 20 years of experience within Regulatory Affairs, working for a number of med-tech companies including Ambu, Radiometer and GE Medical Systems. Lately, he worked four and a half years for ultrasound equipment manufacturer BK Medical. At Medicologic Gert’s primary responsibility will be to support clients by developing classification and mapping of regulatory strategies, creating technical files and design history files as well as preparation and submissions of FDA 510(k) and international applications. Gert will also be working as a QP (Qualified Person) for selected clients.

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R&D work with Medicologic in France could have tax benefits

Medicologic has received the CIR (credit d’impôt recherche) approval by the French Ministry of Research and Higher Education as one of very few Scandinavian med-tech consultancies.

We are really proud of this stamp of approval, says Martin Thomsen, COO of Medicologic

We are really proud of this stamp of approval, says Martin Thomsen, COO of Medicologic

Following an extensive research project in France for a leading client in the health care sector, Medicologic has been granted the CIR stamp. Clients working with Medicologic can now apply for substantial tax credits when carrying out R&D in France.

The tax credit amount given by the French authorities is adjusted according to the degree of basic research and novelty of the R&D, but in some instances it can be the full project costs.

Therefore, this should motivate Medicologic clients with plans in France to look into the possibilities of reducing overall R&D spending.
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Bliv opdateret på de nye regulatoriske krav inden for medicinsk udstyr

Fredag d. 29/4 kl. 8.30 afholder Medicologic og SAXOCON et miniseminar, hvor du bliver opdateret med det seneste nye inden for såvel Medical Device Direktivet, biologisk sikkerhedsvurdering samt CE mærkning af medicinsk udstyr for in vitro diagnostik.


08:30-09:00 Ankomst med kaffe og croissant
09:00-11:00 Velkommen og oplæg
11:00-11:30 Afslutning med en sandwich

09:00 – 09:40
In Vitro Diagnostik samt Medical Device single audit program
• CE mærkning af medicinsk udstyr for in vitro diagnostik – nuværende og kommende regulering.
• MDSAP “Medical device single audit program” – et audit program for samtidig auditering af amerikanske, canadiske, brasilianske og japanske (og europæiske) lovgivningskrav for medicinsk udstyr.
V. Frank Petersen, Lead Auditor fra Presafe

09:40 – 10:20
Biologisk sikkerhedsvurdering af medicinsk udstyr
Er din virksomhed opdateret i forhold til guideline ISO 10993:2009. Følger I den del af guidelinen, som omhandler reduktion af dyreforsøg i forbindelse med den biologiske sikkerhedsvurdering?
SAXOCON præsenterer en løsning med udgangspunkt i ISO 10993:2009, som både lever op til ovenstående og samtidig er den både billigere og hurtigere end den traditionelle og ikke opdaterede tilgang. Løsningen er en gennemprøvet og succesfuld alternativ strategi i arbejdet med at optimere tiden op til en CE mærkning.

Herudover gennemgås hovedtræk i den forestående opdatering af ISO 10993, som forventes at komme i løbet af 2016.
V. Martin Friis-Mikkelsen, CEO samt Niels Hadrup, Senior Toxicologist fra SAXOCON

10:20 – 11:00
Medical Device Direktivet 93/42/EC
Adskillige forslag til ændringer vil skabe en øget regulatorisk byrde for producenter i forbindelse med at bibeholde deres CE mærke på produkter, der allerede er på markedet inden for EU samt for produkter under udvikling med en potentielt forlænget time-to-market.

Medicologic gennemgår de foreslåede ændringer til Medical Device Direktivet 93/42/EC og de udfordringer det kan give.
V. Randi Hauerberg, Principal Advisor – Regulatory Affairs fra Medicologic


Randi Hauerberg has joined Medicologic as Principal Advisor – Regulatory Affairs

As of March 2016, Medicologic has strengthened the organization within Regulatory Affairs and Medical Device Development with a view to the company’s continued development and positive growth.

RandiHauerberg_DarkBackgroundRandi Hauerberg
came on board as Principal Advisor/Team Lead on March 1, 2016. Randi has more than 25 years’ experience within Regulatory Affairs, having submitted and obtained worldwide approval of numerous products within medical devices and in vitro diagnostics such as CE labeling according to MDD 93/42/EC, IVDD 98/79/EC, FDA 510(k) clearances and PMA approvals, Health Canada, CFDA, PMDA, KFDA, Brazil, Mexico, and Russia etc. For the last 5 and a half year she has worked as Regulatory Affairs Lead Manager for BK Medical ApS (Analogic Ultrasound).

Her many years of experience within Regulatory Affairs from manufacturers of medical devices and in vitro diagnostics combined with direct responsibility towards the authorities, contributes to her extensive knowledge about regulatory requirements worldwide in combination with obtaining regulatory approval with a focus upon speed to market and turnkey. Randi has also been appointed as Official Correspondent towards FDA and Health Canada and overall responsible for CE labeling.

She has previously held positions within Regulatory Affairs with Ferrosan A/S, Dako, Radiometer, PNN Medical, and BK Medical. Randi is also Chairman of the RA Expert Group outside EU, a member of the RA Expert Group within EU at Medicoindustrien. She has previously been a member of S-264 which is the Standardization Committee within IVD.

During her many years of experience she has contributed successfully to development projects, clinical, technical, marketing, sales and support, and approval of medical devices and in vitro diagnostics.

Meet us at MEDICA 2015

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, booth D41.

Learn more about MEDICA

Senior Regulatory Consultant with Team Leader Potential


Would you like to be part of a team ensuring the highest levels of patient safety by contributing to the development and approval of intelligent and innovative treatment methods within the medtech industry?

Medicologic is a leading Danish medtech consultancy and engineering company. Together with our customers we bring new and innovative products on the market on time.

We are growing and thus need additional resources for our RA & Quality Team.

Your Job and Key Responsibilities
Reporting directly to the Managing Director you will lead and develop the RA & Quality Team as well as interact with our customers with regards to both generating opportunities as well as hands-on RA & QA assignments.

Bringing our customers products to market – requires your – and your team’s, solid competence with regards to both the CE mark approval, CE testing for Medical Devices (MDD) processes as well as the processes required for FDA, 510K registration plus PMA.

Desired Skills and Experience
Our preferred candidate has the following personal and professional qualifications:

– Relevant pharmaceutical or engineering degree, B.Sc or M.Sc
– Minimum 5 years of experience in related position
– Firm knowledge of CE mark approval, CE testing for Medical Devices (MDD) as well as FDA, 510K registration and PMA
– Training/teaching experience is seen as an advantage but not a requirement

Competencies (Professional as well as Personal)
– Solution oriented with an excellent ability to identify cost-effective angels to regulatory requirements and quality assurance demands
– You have a very strong collaborative approach towards the stakeholders
– You are a good listener with strong communicative skills
– Strong cultural awareness and a global mindset
– Fluency in English and at least one other Scandinavian language
– Leadership skills and a motivating appreciative approach to people management
– Outgoing personality with the skills to facilitate and lead projects

What we offer

We offer a challenging environment with build in opportunities for growth both professional as well as personal. We are a company with growth potential and concrete growth plans. Our customer centric approach to consultancy gives you an insight into cutting edge development both in Denmark and internationally.

We would like to welcome you in our engaged, warm, positive, fast and professional environment with social events amongst colleagues as well as professional sparring from highly experienced experts in order for you to have an engaged daily work experience as well as professional growth opportunities while working. Also we offer a competitive compensation package with both pension and insurances.

Contact information
If you want to know more about the job you are welcome to contact Michael Funder on +45 2064 4146 or

Send your application
Send your application including CV to CEO, Michael Funder Deadline is Jan 15, 2015.
We will conduct interviews on an ongoing basis.

We look forward to hearing from you.

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