Free Micro-Consulting for Med-Tech Companies
Get your questions answered
For MedTech companies
Use our Micro-Consulting to get ahead!
Specific questions often arise in day-to-day work to which no satisfactory answer can be found internally in a hurry. That’s when good advice is needed to keep things moving forward. We offer you an uncomplicated and free opportunity to discuss your question with one of our experts. We are happy to share our knowledge and experience with you to help you move forward.
Do you have a question related to your technical documentation, the right way to deal with your Notified Body, or how to realign your supplier relationships under the MDR? Whatever topic is currently on your mind – take the opportunity to talk about your questions with us!
Medical device development
Quality management and Regulations
Business-Development & Financing
At 3R LifeScience, we ensure that you have full control over the development of your products and your company despite of the MDR.
“When words were followed by actions and actions by results, I was more than convinced! Thanks to 3R LifeScience, we were able to successfully complete more than a singular product development and bring a product to market that has a great impact for our patients.
In addition, we were able to do a great deal of groundwork of an organizational nature within the company, from which we will benefit in the long term.”
Berlin Heart GmbH
Confidential and free micro-consulting in 3 steps
Book your appointment easily and directly via our calendar portal. Choose a time slot that suits you best.
Describe your challenge to us as comprehensively as possible but to the point. We will ask questions, point out possible options and provide valuable input.
After the discussion, it is up to you to further think through and implement the solution approaches. If you would like further support, we are here for you.
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.
Dipl.-Ing. Sebastian Kallenbach – Project manager
Sebastian Kallenbach has many years of experience in the development and certification of active and passive medical devices of classes I-III. Based on his professional background as an electrical engineer and his experience as a department and project manager, his specialty is the project management of development projects as well as the setup and establishment of R&D and interface processes.
At 3R LifeScience he supports you and your company in the successful implementation of development projects as well as in the MDD-MDR transition.
Dr.-Ing. Janin Leuckert – Projektmanagerin
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 managerin
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.
These companies have secured their successful future in MedTech world through our collaboration:
We guarantee that every conversation and the information discussed in it will be kept strictly confidential.