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 founders have instructed, facilitated and consulted to the Scandinavian medtech indsutry for many years.
Co-Founder - Course Admin.
Kristian consults in medtech innovation, as a business developer and facilitator. Boundary spanning the healthcare eco-system, he facilitates access to knowledge, markets and technology.
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.
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.
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.
DK-2800 Kgs. Lyngby
Phone: 40 93 11 33
CVR NR 37327603
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