About

Your trusted regulatory consultancy

In a dynamic, fast-paced world in which, on the one hand, innovations and progress are becoming possible at an ever-increasing rate, but on the other hand, bureaucracy and regulatory requirements are constantly increasing, a conflict arises between what is technically possible and what is feasible for companies.

We support you in mastering the challenges of the life sciences industry!

 

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Photo of Lukas Losigkeit (CEO)

Excellence is key!

My name is Lukas Losigkeit. I am the CEO and founder of thinqbetter, and I am personally committed to your satisfaction!

  • My goal: eliminate problems.
  • My motivation: avoid unnecessary bureaucracy.
  • My passion: pragmatic, compliant solutions.
In a dynamic, fast-paced world in which, on the one hand, innovations and progress are becoming possible at an ever-increasing rate, but on the other hand, bureaucracy and regulatory requirements are constantly increasing, a conflict arises between what is technically possible and what is feasible for companies. This conflict reduces the innovative strength of the life science industry and inevitably leads to the industry falling short of its innovation potential.

We cannot resolve this conflict because we have no corresponding political influence. However, we can support our customers in this environment to remain as innovative and marketable as possible.

We identify solutions, provide support and guidance. In doing so, we consciously set ourselves apart from other companies in our industry, which tend to motivate their customers to work together by stirring up fear and uncertainty.

We want to achieve our customers' goals together with them, based on our company's core values, which we believe always results in a win-win situation. We stand for trust, customer satisfaction and reliability.

Extensive projects

Start from scratch:

Support during company founding, establishment of a quality management system from scratch, design and development, conformity assessment, and subsequently as Person Responsible for Regulatory Compliance (PRRC).
2022 - 2025
MDR - (EU) 2017/745
Enter the medtech industry:

Supporting an established company in becoming a manufacturer of medical devices: Setting up an ISO 13485 QMS, preparing technical documentation, and subsequent collaboration as management representative and PRRC.
2021 - 2025
MDR - (EU) 2017/745
Transition to the Regulation:

Supporting manufacturers with in part over 150 devices in the transition from MDD to MDR and from IVDD to IVDR. We assisted with strategic planning, updating and simplificating tech files and preparing for the conformity assessments.
2020 - 2025
MDR & IVDR (EU) 2017/746

Innovative projects

AI software:

Support during development of AI medical devices, creation of the technical documentation and preparing for the conformity assessment.
2024 - 2025
MDR - (EU) 2017/745
3D printing:

Strategic planning of device iterations and stepwise launches with subsequent conformity assessments; creation of tech files and the QMS.
2023 - 2025
MDR - (EU) 2017/745
Absorbable implants:

Support in creating technical documentations for absorbable implants, including biological and clinical evaluations.
2021 - 2022
MDR - (EU) 2017/745

Clinical affairs

Biological evaluation:

Creation from scratch or updates for devices with direct or indirect patient contact.
MDR - (EU) 2017/745
Clinical evaluation:

Creation from scratch or updates for all kinds of medical devices and risk classes.
MDR - (EU) 2017/745
Performance evaluation:

Creation from scratch or updates for different IVDs and risk classes.
IVDR - (EU) 2017/746

Request information

Please feel free to contact us with your questions!

One of our consultants will contact you shortly after receiving your inquiry.

Confidentiality and discretion are important to us. Therefore, we will treat your inquiry accordingly, even before entering into a confidentiality agreement.

Contact

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