Archive for March, 2017

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.

IMG_7838-Randi Hauerberg

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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