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 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.