Recent News

Strong insights and human factors design result in brilliant product

Danish biotech company CytoVac A/S benefits from simple Medicologic innovation.


Finding the right solution can be a tricky process. However, once you overcome the many obstacles and find a successful way to move forward – you often wonder why it took so long. This is also the experience at CytoVac, a Danish biotechnology company developing a new immunotherapy method for treatment of cancer based on live cells.

CytoVac’s research is based on growing cell cultures that are cultivated in flasks. But ordinary cell culture flasks have their limitations. On the one hand they require quite a lot of space – but even more important is the fact that the liquid growth media as well as the size of flasks need to be changed frequently.
Learn how a flask design can improve laboratory results and efficiency.

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New US FDA 510(k) Draft Guidance for Deciding When to Submit a 510(k) for a Change to an Existing Device: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Then you need to be aware of that the FDA on August 8 has issued an updated draft guidance for manufacturers deciding whether to submit a new 510(k) when making modifications to medical devices already in the market.

Furthermore, a complementary draft guidance on software modifications was also issued.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 FDA also drew from existing policy and related guidance in updating the draft guidance document, including: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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Medical devices: deal reached on new EU rules

On 25 May 2016, the EU agreed new rules on medical devices and in vitro diagnostic medical devices.

eu mapThe Netherlands presidency of the Council and representatives of the European Parliament reached a political agreement. It is still subject to approval by the Council’s Permanent Representatives Committee and of the Parliament’s ENVI committee.

The agreed two draft regulations are expected to achieve a twofold aim: making sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit from innovative health care solutions in a timely manner.

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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.