ARE YOU READY FOR MAY 2020? In May 2017 the new Medical Device Regulation (EU) 2017/745 was adopted, replacing Medical Device Directive 93/42/EEC. The new Regulation is based on a wish to ensure increased safety and quality of medical devices that are sold and distributed within the EU. The new Regulation deals both with products already CE marked as medical devices and with products under development, and has led to significantly increased requirements, also within safety and efficiency. The three-year transition phase from the Directive to the Regulation entering into force means that manufacturers have until May 2020 to meet the new Regulation requirements. Here you have a few tips on how to get started: https://lnkd.in/efX4zha

SEASON'S GREETINGS Wishing you all a joyous holiday season and a prosperous new year. We thank our customers and partners for the good cooperation in the past year and look forward to a new and exciting 2018.

Join us in introducing new medical devices to market. You take charge of complex core projects from the initial customer contact to the final approval is secured, focusing on speed to market. And you do so for the biggest players in the field and the medical device start-ups. Would you like to help introduce new medical devices in a market facing significant regulatory changes in the years to come? https://www.jobindex.dk/jobannonce/278515/regulatory-affairs-senior-principal-advisor

We are hiring! Learn more and apply for the position here: http://medicologic.com/senior-regulatory-affairs-specialist/

Having Vibeke Harbud onboard Medicologic now offer services such as business case development and competitor and market analysis leading to economic implications. Learn more http://medicologic.com/strengthening-our-capabilities-within-commercial-business-development-agreement-with-vibeke-harbud/

We are hiring! Learn more and apply for the position here: http://medicologic.com/senior-regulatory-affairs-specialist/

We are happy and proud to welcome another two colleagues to our skilled team at Medicologic: Carina Hoffmann Vargas, Regulatory Affairs Consultant and Knud Lykke Jensen, Senior Consultant, Quality Assurance & Regulatory Affairs.

Come join us at our seminar! https://lnkd.in/gkgRsyV

Medicologic participates at the annual Drug Device Combination Products conference, 6-7 December in Berlin. https://lifesciences.knect365.com/drug-device-combination-products/ The area of combination products is constantly evolving and we are continuously updating our knowledge, experience and network. Let us help you speed up the process of bringing combination products to market! * Strong R&D competences * Remarkable RA track record * Extensive QA experience

News from Medicologic:

We are looking for a creative and experienced Product Developer for our Research & Development Team. #researchanddevelopment #medicaldevicedevelopment #medtech http://medicologic.com/product-developer-2/