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Lesley Gjelstrup Kristensen joins Medicologic as Senior Consultant, Regulatory Affairs & Quality Management

As of May 2019, Medicologic has strengthened the organization within the Regulatory Affairs field to meet the continuous company development and positive growth.

Lesley Gjelstrup KristensenLesley Gjelstrup Kristensen came on board on May 1st 2019. Lesley has more than 10 years’ experience within Medical Device Regulatory Affairs both as Manager and with hands-on experience.

She has submitted and obtained approvals for Class III Medical Devices and Combination Products from e.g. EU, FDA (PMA), Health Canada, TGA and PMDA and has worked intensively with the MDR transition preparing company GAP analysis to identify the consequences of MDR and ensure compliance in a timely manner.

Lesley also has extensive experience with Design Control of Quality/Regulatory requirements following FDA regulation 21 CFR 820, MDD 93/42 / MDR 2017/745 and ISO 13485:2016. For the last 4 years she has worked as Regulatory Affairs Manager for Ferrosan Medical Devices A/S.

Her many years of experience within the Medical Device Regulatory Affairs field combined with her being responsible for all coordination and contact towards the authorities, contributes to her extensive knowledge about regulatory requirements worldwide in combination with obtaining regulatory approval with a focus on how to get products safely and fast to the market.

She has also been involved in MDSAP stage 1 and 2 company inspections ensuring regulatory compliance and approval.

During her years of experience she has contributed successfully to development projects, regulatory strategies, marketing & sales, supply chain resulting in approvals of Class III Medical Devices and Combination Products worldwide.

Welcome to our RA blog –

It is a pleasure to introduce our new RA blog.
Being your global partner within RA/QA we would like to share our new RA blog with everybody who has an interest in what is going on in the complex world within regulatory affairs and medical devices.

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Keeping you up-to-date with RA/QA
During the last 10 years, the evolvement of legislative requirements within the RA/QA and medical devices area has expanded massively. Working within the RA/QA area being on forefront with new and constantly changing legislation can be a daunting challenge – we would therefore like to help you gain an overview.

On we will post news and articles describing different issues within RA/QA enabling you to be on the forefront with legislative issues worldwide.

We pride ourselves in making a difference!
Medicologic is a management consulting company specialized within the RA/QA area and medical devices.

Our employees have more than +25 years of experience with the full lifecycle of RA/QA within the medical device area. We pride ourselves of being on the forefront of legislation and interpretation of what is the impact for manufacturers and economic operators.

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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

    Michael Funder, CEO
    Direct (+45) 20 64 41 46

    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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