Recent News

Adding further Design Controls and Project Management experience to our Team – welcome to Søren Bundgaard

As part of a continued focus on delivering high-value RA/QA consulting for medical device companies, Medicologic has hired Søren Bundgaard in the role as Senior Consultant, Design Controls & Project Management.

Søren has many years of experience from the medical device and instrument businesses, where he has worked for international companies such as Medtronic, Natus Medical and Bruel & Kjaer, both as a manager and hands on.

Søren Bundgaard-orgHe has held positions including function and business management on a senior level, following project manager positions, which evolved from his original background as M.Sc. in Electrical Engineering.

Søren has a broad knowledge within design control of quality/regulatory requirements following FDA regulations CFR 820, MDD 93/42/EEC, EN ISO 13485, EN ISO 60601-1, EN ISO 60601-1-2, EN ISO 62366, EN ISO 62304 and risk management according to EN ISO 14971.

Søren is a pragmatic, constructive and straightforward person and he works well with his stakeholders – up and down in the organization – and can present status and issues clearly and precisely.

“With Søren aboard we will add further competencies to our highly qualified team on major RA/QA areas, helping our clients succeed in a very dynamic and complex market, says CEO Michael Funder.“

Additional 30 years of experience to our Quality Management & Regulatory Affairs Team – welcome to Eva Steinick

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

LES_170817_00012Eva has more than 30 years of experience within Quality Management and Regulatory Affairs, both as manager and hands on. Eva’s experience covers both medical devices and in vitro diagnostic devices.

Eva is a trained lead auditor and she has conducted numerous internal and supplier audits in Europe and North America.
Eva has submitted several international registration files for Class III medical devices and in vitro diagnostic devices and handled complaints, non-conformities and CAPAs, risk management, adverse incident reporting and Field safety corrective actions.

She has been part of implementation of Quality Management systems, writing and updates of procedures, and GAP analyses.

Eva is an expert in Design Controls and she has also worked as Project Manager in the telecom industry.

Furthermore Eva is a dedicated person who strongly believes that every problem has (at least) one smart solution.

According to Partner Randi Hauerberg, this is yet another positive addition to our expertise across all major RA/QA areas. “Eva has worked with medical devices and in vitro diagnostics and has extensive knowledge when it comes to EU Directives, FDA regulations, EU harmonized/internationally recognized standards and MEDDEV guidances – all areas where experience plays a key role in obtaining a fast and smooth process for obtaining approvals for our clients. I am sure Eva will prove a major asset for us and help our clients succeed in this very dynamic and complex market”.

Strengthening our capabilities within commercial business development – agreement with Vibeke Harbud

Having Vibeke onboard Medicologic now offer services such as business case development, competitor and market analysis including user feasibility and key opinion leaders interviews leading to economic implications.

Vibeke Harbud PortrætVibeke holds almost 30 years of experience from commercial business development in the pharmaceutical industry. She has worked in both national and international marketing positions and the last good ten years in Business Development developing business cases from which she has developed tactics and strategies.

Due to her extensive experience, including positions at Nycomed (now Takeda), Lundbeck, LEO Pharma, Ferrosan and AstraZeneca, Vibeke has a strong understanding of the commercial and marketing areas.

Vibeke holds a BA in economics, an eMBA and the first year of a Master in Communication, and is an authorized nurse. She has worked with numerous therapeutic areas and with orphan drugs and herbal remedies.

The service portfolio includes all aspects of financial valuation and the interaction with investors or other pharmaceutical companies, providing clients with end-user and economic perspective throughout a project.

Examples of services

  • Business case including NPV (net present value) and risk adjusted NPV
  • Description of the market
  • Establishing market need
  • Matching the needs with product profile
  • Establishing of the market potential:
  • Establishment of prevalence
  • Target population
  • Treatment centres / current treatment practice
  • Validating the TPP (target product profile)
  • Competitive environment
  • General market understanding through Key Opinion Leaders interviews
  • Establishment of anticipated costs and resources
  • Assumed sales and marketing spending
  • For more information:
    Randi Hauerberg, Partner
    Principal Advisor/Team Lead – Regulatory Affairs & Quality Management
    Direct (+45) 22 47 01 55
    rh@medicologic.com

    Michael Funder, CEO
    Direct (+45) 20 64 41 46
    mf@medicologic.com

    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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    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.

    cityvac02_32x13_liquid_7

    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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