Regulatory Consulting and Medical Device Consulting: Our regulatory affairs consultant are experts for EU and US market.
  • Clinical Evaluation Report under the medical device regulation MDR EU 2017/745. Clinical evidence for device classes I to III

    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.


  • Risk Management for medical device and IVD - ISO 14971

    Customer satisfaction

    Your satisfaction is our highest goal in all projects. A project is only successful for us if you are satisfied!


  • Quality Management Consulting - ISO 13485 and MDSAP

    Reliability

    Have you had an authority or notified body announce its intention to audit 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

ABOUT US

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!

Lukas Losigkeit

Our Expertise

Our expertise is at your disposal. The following examples are only a slight overview of what we can provide. We are capable to assist you even in the most complex projects. For a more detailed list of our global regulatory consulting services, click here.

Are you looking for support in the area of regulatory services and consulting?


With us you are at the right address!

  • Are you looking for experts at fair prices?
  • Do you wish a trustful cooperation?
  • Do you attach the greatest importance to a successful project completion?
  • Do you like to reach your goal in an uncomplicated and efficient way?
  • What are you waiting for? We look forward to your message!
  • Overview
  • Audits & Training
  • Market access
  • Quality management
  • Safety & Performance
  • Clinical Investigation & Studies
  • Software

ANVISA RDC 16

You need to comply to RDC 16?
You need a brazilian GMP certificate?
We make you audit ready!
Ask also for RDC 23 and more.

Audit preparation

FDA, ANVISA or any other plans to
audit your company? We make you
audit ready! E.g. by mock audit or
conducting a gap analysis.

Biological evaluation

We create and update
biological evaluations for devices
with patient contact.

Clinical evaluation

We create and update
clinical evaluations for all
medical devices. Additionally we
offer trainings and workshops.

Clinical investigation

We support you to plan and conduct
clinical investigations for an initial
device registration.

Computerized system validation

Software / CSV within your QM system
needs to be validated? We assist you
in conducting these validations or
we simply validate for you.

IEC 62304 and IEC 82304-1

With our partner we develop medical
device software, health apps, the
electronic health records for health
insurances and many more.

Initial certification

For initial certification of your QMS
we support your company in project
planning and communication with
the authority or notified body.

PMCF study

We support you to plan and conduct
PMPCF studies for devices that are already
on the market.

Quality Management

We create compliant QM systems
from scratch, or make your existing
QMS compliant to ISO 13485 or
ISO 9001.

Risk Management

Risk management is mandatory. We
create RM processes and assist you
to compile the risk management file
according to ISO 14971.

Device registration

We support you to register IVDs
and medical devices in EU, USA, and
other MDSAP member states.

IVDR (EU) 2017/746

You want to manufacture IVDs
under IVDR (EU) 2017/746?
We support you to gain market
access and create compliant processes.

MDSAP

Medical Device Single Audit Program
- We assist you in project planning,
gap identification and closing, and
during the audit.

MDR (EU) 2017/745

You want to manufacture medical
devices under MDR (EU) 2017/745?
We support you to gain market

Performance evaluation

We create and update
performance evaluations for all
IVDs. Additionally we offer
trainings and workshops.

Performance study

We support you to plan and conduct
performance studies with IVDs.

Post-market surveillance

We create processes for PMS,
compliant to MDR (EU) 2017/745 and
IVDR (EU) 2017/746. We support you
with your PMS activities.

Technical documentation

We support you in setting up
the technical documentation for your
products, or perform a gap analysis to
determine its compliance.

Training

We provide different trainings,
e.g. for risk management (ISO 14971) and
quality management (ISO 13485 / ISO 9001).
Contact us for further details and topics!

21 CFR 820

The FDA´s quality system regulation
is a big obstacle prior market access
in the USA. We make you compliant
and audit ready!

OUR MISSION

Through our core values, trust and reliability, we want to create an atmosphere in which our customers can develop their maximum potential. Our goal is not just mutual success. We strive for synergies and new standards of efficiency!

Our experience is that the medical device and IVD industry is affected by many uncertainties and sometimes even fear. Regulatory requirements, new and upcoming, are the reason for this. This creates a situation in which creativity and innovation are suppressed. We want to change exactly that.

thinqbetter supports you to ensure your innovation will find its way to the patient! Health is an essential need for a happy and delightful life. All humans shall have access to high quality healthcare all over the world. Let us together make the world a little better!

WHY CHOOSE US

  • Because we take you and your concerns seriously.
  • Because we focus on your satisfaction.
  • Because you appreciate being treated at eye level.
  • Because expertise and reliability are important to you.
  • Because you do not want to be disappointed by service providers.
  • Because you get all this only from us!
  • Climate Protection

      Regulatory Consulting and Medical Device Consulting: Our regulatory affairs consultant are experts for EU and US market.

    • We have developed a four-
      stage climate protection
      concept. The goal is to become
      completely CO2 neutral.
  • Cooperation Partners

      Regulatory Consulting and Medical Device Consulting: Our regulatory affairs consultant are experts for EU and US market.

    • Through close collaboration
      with cooperation partners,
      we can support you in all
      areas of medical technology.
  • Customer Satisfaction

      Regulatory Consulting and Medical Device Consulting: Our regulatory affairs consultant are experts for EU and US market.

    • Our superordinate goal
      is to ensure the
      satisfaction of all
      our customers.

Read our betterblog!

Because it has never been easier to understand regulatory topics.

Post-market surveillance fundamentals - betterblog.

Post-market surveillance

What is post-market surveillance and how does it work? - Basics of PMS.

Read
Registration / Approval of class I medical devices

Medical Device Class I

Approval process, QM system, technical documentation and competent authorities..

Read
FDA registrations for medical devices - part 1

FDA registrations - Part 1

How to bring your medical devices legally into the U.S. market?

Read
Find out more

Contact

We very much look forward to getting to know you!


Detailed information on the handling of user data can be found in our privacy policy

+49 40 604 2992 - 0
info@thinqbetter.com

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Operator

  • thinqbetter GmbH
  • Hongkongstraße 6
    20457 Hamburg, Germany
  • Commercial Reg. HRB 159645
    VAT No. DE326776751
  • Imprint
  • Privacy policy

Representatives

  • Lukas Losigkeit (CEO)
© 2019 - 2024 thinqbetter - All Rights Reserved.