Recent News

New QA cooperation reinforces Medicologic capabilities – agreement with QA expert Stig Larsson

As a result of increasing demands for high-value QA services, Medicologic has entered an agreement with Stig Larsson – renowned as a leading QA expert in the medical device industry.

StigLarsson-redThe QA management field within medical device is changing rapidly these years and especially the upcoming CMDCAS / MDSAP requirements will impact many medical device and in-vitro diagnostics companies in the years to come.

Stig brings 30 years of experience within Quality management working both in the industry and as an external lead auditor. He has worked in numerous parts of the medical device industry as well as in other industries both in Europe and North America – and held key management positions responsible for projects, quality and logistics.

Medicologic clients are requesting consultants with good understanding of accredited certification and Notified Bodies, and with Stig’s experience from DS/DGM (Danish Standard association) and BVQI, this is expected to be a major asset for the future.

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Randi Hauerberg becomes partner in Medicologic A/S

After one year of employment Randi Hauerberg becomes partner in Medicologic A/S.

Randi Hauerberg came on board as Principal Advisor/Team Lead on March 1, 2016 and has since then contributed with her professional expertise and personal skills to the positive development of the Regulatory Affairs & Quality Management business in Medicologic.

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Through our partnership we are looking forward to the fantastic opportunity of being able to grow Medicologic as one of the leading international management consulting companies helping customers particularly within the Regulatory Affairs & Quality Management area.

Medicologic’s customers are customers within the Medical Device segment who are facing tremendously challenges within the regulatory and quality management area by constantly, complex and changing legislative requirements in order to obtain or maintain approval of their medical device products.

“Based upon the constantly changes within the legislative area, and particularly within the forthcoming new regulation within Medical Device and IVD I see – during the next 3 to 5 years – a fantastic opportunity helping our customers through the complex regulatory landscape”, says Randi Hauerberg.

Our competences within Regulatory Affairs & Quality Management is based upon highly skilled, professional consultants with more than 25 years’ experience helping customers through the least burdensome pathway with emphasize on speed-to-market and turnkey.

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Medicologic is beefing up on combination product expertise

Complete combination product team in place with new associate

The development of combination products is speeding up, and many pharmaceutical companies view the “diagnostic or therapeutic products that combine drugs, devices, and/or biological products” (as defined by FDA) as a key part of their new product pipeline.

Handshake-redIn many cases, firms are dusting off their older drugs and generating new intellectual property around a new delivery technology.

The most common types of combination products are pulmonary inhalers (eg, dry powders or pressurized aerosols), injection systems (e.g. pen injectors and auto-injectors), and infusion systems (e.g. ambulatory syringe pumps delivering continuous subcutaneous drug delivery).

Other types include nasal sprays, creams, eye drops, and ear drops.

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Strong insights and human factors design result in brilliant product

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

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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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