MEDQURE provides you with training to develop your knowledge, skills and competence.
We've put together courses that will develop your professional expertise keeping you up to date with new information relevant to the regulatory field of medical devices.
MEDQURE's instructors are very experienced having instructed and consulted to the Scandinavian medtech industry for many years.
We look forward to seeing you.
Co- Founder - Course Instructor
Micael is a senior regulatory and quality consultant. He sits on the MEDEA board and consults to start ups and large companies in Europe. He is a member of the standard committee TK62 and TK66. (TK62 handles the EN 60601 - series and TK 66 handles the EN 61010- series) He has held many course in Denmark and Sweden. His instruction is empowering and hands on.
Dr. Chao Xu
Dr. Chao Xu. is the Managing Director of Europe Branch of OSMUNDA Group. After graduating with a bachelor degree in Biomedical Engineering in Shanghai Jiaotong University and working shortly in Siemens China, she moved to Berlin and gained her master and Ph.D. degree in the Charité, Berlin Medical University. During this period, she worked as a research scientist in the Max‐Planck Institute, Leipzig and directed clinical trial in close collaboration with Siemens Diagnostic Imaging Division.
From 2011, she joined OSMUNDA as a consultant for regulatory affairs in the Europe CE‐marking and China CFDA approval.
In 2013, she was appointed the Managing Director of Europe Branch and is responsible for international business and collaborations. She speaks fluent English, German and Chinese.
Mats' areas of expertise are: CE-requirements for Medical Devices, Quality Management, Risk Management, Medical Information Systems (SaMD), Standardisation, Accident investigations, Communication and teaching.
He has actively participated in EU committees NBOG and COEN, represented EU in IMDRF Software as Medical Devices working Group and since long-term member in a number of IEC/CLC and ISO/CEN standardization committees. He is a trained auditor and assessor for medical device manufacturers and Notified Bodies.
With almost 30 years of experience from medical device and pharma industry as QA, RA, QP and the tasks within those fields as well as clinical affairs, toxicology and biocompatibility Anette will share her learning and industry practice with you in the courses.
Anette is a member of the Swedish (TK355) and the international technical (TC210) committees of ISO 13485, ISO 14971, IEC 62366 and was also part of the international PMS task force. The knowledge and her learning from standardization work will also play an important part in the courses. Since 13 years Anette is a consultant within PREVENTIA and gives courses company internally, at conferences or as an external educator every month.
Anette has a MSc in Biomedicine.
Peter Sebelius (PMP) has a vast experience as manager in the medical device industry and is an esteemed trainer. He is a member of standard committee TK355. Among the many awards that he has received is the Great Design Award and the title “This year’s specialist 2009” by Veckans affärer.
Petter is a senior advisor and solution lead focusing on business transform-ation in product development and design controls from the Nordic and international medical device and high-tech industries. In his daily work he performs readiness assessments and change management in regulatory, quality assurance and product development processes – often with the task of implementing concurrent engineering and reducing lead time in to regulatory release, product or materials compliance processes. Over the last years he has followed the developments on substance regulations closely and run a number of courses on the implementation of RoHS, REACh and conflict minerals – always with real and relevant examples and exercises.
Co-Founder - Course Administration
Kristian administer and markets MEDQURE's courses.
Working in design management and marketing, he has developed an acumen
for facilitating access to knowledge, markets and technology.
He consults on medtech innovation, facilitating ideation worskhops. From the frontend of product development he has consulted to life science SME's and large enterprises.
Kristian has an MBA in Design Managment
DK-2800 Kgs. Lyngby
Phone: 40 93 11 33
CVR NR 37327603
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