The 3R LifeScience Team – Medical Devices Experts
Dr. Veit Otto – Managing Director
Dr. Veit Otto has many years of experience in the management of medical technology companies. During this time, he led, among other things, a spin-off from a one-man operation to a company with 140 employees and 40 million euros in sales.
At Pulsion/Getinge, as CTO, he was responsible for development, regulatory affairs, QM and production. He was also instrumental in leading a complex development project of Berlin Heart to successful certification in compliance with MDR.
For several years, Dr. Otto has now been helping companies successfully implement the MDD-MDR transition.
Dr. Michaela Hajek – Managing Director
Dr. Michaela Hajek supports your company as an experienced management and technology expert. Her focus is on interface management and in the risk management-based, goal-oriented development and approval of medical devices. She is also a specialist in establishing and maintaining quality-relevant management processes throughout the entire product life cycle.
Her activities at 3R LifeScience include senior interim management and leadership of R&D projects, regulatory approval and certification activities, and the establishment of QM systems and quality-related processes for product safety and market tracking.
Dr.-Ing. Janin Leuckert – Project manager
Dr.-Ing. Janin Leuckert has several years of experience in the strategic and operational execution of research & development projects. She supports your medical device development in the execution of the mechanical design as well as in the transfer into a reproducible product.
In the past, she was responsible for the project management of an active medical device from feasibility study to completion of verification. Through the consistent application of risk management, Dr.-Ing. Janin Leuckert at 3R LifeScience now supports companies in project execution with internal and external stakeholders.
Anke Abt – Project manager
Anke Abt has many years of experience in the strategic and operational development of QM systems and the adaptation of existing QM systems to the constantly growing regulatory requirements in medical devices.
At 3R LifeScience, she focuses on process management with a holistic approach. This means that she establishes processes aligned with your corporate goals as well as taking into account your corporate risks and the legal and regulatory requirements.
Karsten Wilke – Project manager
Dipl.-Ing. Karsten Wilke has many years of experience as the production manager of a medical device manufacturer. During this time, he developed the team, production, customer service and the supply chain of the company. He is used to achieving goals and meeting deadlines with the team through agreed, clear targets. Crucial to his success is involving all employees involved in the process in the development and giving them responsibility for it.
At 3R LifeScience he helps customers with supplier management as well as with the rapid design transfer from development to production. As an enthusiastic team player, he is skilled at adapting to new tasks and situations through a high degree of flexibility and resilience.