Consulting the life science industry
think better -
think quality
Your competent consultants for regulatory consulting
in medical technology!
Why choose us?
Trust
Trust is one of our most important values. That is why we attach great importance to the security of your data and exchange them with you only via secure servers in Germany.
Customer satisfaction
Your satisfaction is our highest goal in all projects. A project is only successful for us if you are satisfied!
Reliability
Do you have to solve a critical issue at short notice? Together we can do this - if necessary, even with a night shift. Because we are always available for our customers.
Regulatory Consulting
in medical technology
thinqbetter stands for a future full of prospects: Because we show ways where others only see obstacles.
Together with us, you can turn regulatory requirements into a valuable advantage over those who do not know that direction. We work with core values for which we stand. Trust and reliability are our compass!
We offer regulatory consulting services in medical technology. Are you a manufacturer of medical devices or in vitro diagnostics? Then we are the right partner for your device registrations and quality management in the EU and the MDSAP member states!
Please feel free to contact us without obligation to discuss your concerns. We look forward to hearing from you!
Management
My name is Lukas Losigkeit and as CEO of thinqbetter I personally vouch for your satisfaction! The cooperation with our customers is based on the core values of our company, because only through trust and reliability we can be a good partner for you. This is the only way we can satisfy you and ultimately ensure the success of your project.
Customer satisfaction is not just an empty phrase for us, but our most important goal!
Providing excellent consulting
Our customers are players in the life sciences industry: manufacturers of medical devices, IVDs, importers, distributors, authorized representatives, and individuals or companies seeking to fulfill these roles.
We don’t just advise, we create solutions and support with implementation.
Your project success and satisfaction are our goal!
Let's talk numbers
Our Services
Are you looking for support in the area of regulatory services and consulting?
With us you are at the right address!
We offer consulting and services for biological evaluations. In addition to creation, updating and correction, we support you in developing efficient strategies.
We offer consulting and services for clinical evaluations. In addition to creation, updating and correction, we support you in developing efficient strategies.
We offer consulting and services for performance evaluations. In addition to creation, updating and correction, we support you in developing efficient strategies.
We offer an external PRRC service for micro and small enterprises as defined in 2003/361/EC.
MDSAP covers the quality management requirements of Australia, Brazil, Japan, Canada and the USA. We can assist you with all matters relating to this topic!
Quality management – ISO 13485
Establishment and improvement of quality management systems according to (EN) ISO 13485.
We are your reliable partner for the approval of your medical devices and IVDs!
Risk management is a legal requirement for medical devices and IVDs. We support you in applying EN ISO 14971 as well as in specific methods such as FMEA.
We are your partner for all regulatory aspects of medical devices in the USA. We support your market access – for example, with a 510(k) submission!
Why Choose Us
What Sets Us Apart
Customer satisfaction
Our most important KP
Close collaboration
You´ll never walk alone
Communication at eye level
Mutual respect and recognition
Efficient projects
Sensible use of project resources
Company values
Trust, customer satisfaction, reliability
Emergency support
We are here when you need us
Testimonial
"We worked together really well, both professionally and in terms of communication."
"Incredibly great company with absolutely enriching professional expertise."
"The cooperation was excellent. The quality and quantity of results were absolutely convincing!"
Request info
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 we conclude a confidentiality agreement.
