Consulting and support
for manufacturers
of medical devices
tecurat GmbH – Experts of the industry for the industry
Interims management
Competent & retrievable
Your search for experts ends with us! Your tecurat team unites a broad variety of competences, supporting your staff and giving them a secure stance during all phases of your medical device – adapted to requirements & flexible in terms of time.
Process design
Strategic & efficient
We analyze your internal structures and consult you on how to optimize your process and data management via targeted adjustments.
This way, you will stay on course and can react confidently & agilely when the requirements change.
Knowledge transfer
Comprehensible & sustainable
In addition to guiding and implementing work packages, we work with your team to get them fit with our training courses so that your employees know all product-relevant specifications and implement them resource-optimized & pragmatically in everyday life.
Increased need for personnel?
Do you urgently need qualified specialists?
Oversized processes?
Too high friction loss in your internal processes?
Limited expertise?
Do your departments need topical training?
Do these topics sound familiar to you?
Then take advantage of our experience in the medical device industry
tecurat GmbH – Your MedTech experts
for all topics relating to your safe & high-performance medical device.
Our services:
Digital Transformation
Gain an edge
We will show you how to digitally map your process documentation, so you can transfer your operating information into knowledge.
QM Consulting & Audit
Compliant implementation
Redesign or review – With strategic fore-sight, we will optimize your QM system and support upcoming audits.
Technical File
Complete recording
We will assess your technical documentation for completeness and consistency to point out potential for improvement.
Worldwide approval
Successful certification
With in-depth knowledge of the regula-tions, we are at your side to advise you on all approval-relevant issues.
Clinical Affairs
Early consideration
6We support the collection of relevant data on the clinical benefit of your medical product. So that the patient remains in focus.
Start Up Know-How
Igniting drive
Take advantage of our special training offer for young companies. For a smooth start into the "MedTech" universe.
Development Support &
Technical Documentation
Clinical Evaluation, Clinical Trial & PMS
Quality Management & Audits
Tool Specification, Configuration & Validation
Reinforcement for your team & Interims Management
Regulatory Updates, Briefings & Training Courses
tecurat GmbH -
Your ideal partner for your medical device if you
- Need a wide range of expertise from the MedTech industry
- want to implement functional quality & risk management
- want to complete your audits at a regular pace and well prepared
- Resolutely want to take the path to digital data management
- Wanting to bring safe & innovative products to market quickly
- Want to focus on your original core business again.
Statements by our clients
COMPUGROUP MEDICAL SE & CO. KGAA
As support for the preparation for MDR and audits, we were looking for external support to supplement missing capacities but also know-how.With tecurat we learned about a goal-oriented and pro-active approach.
They did not only work with single templates but with an overview of the whole context and an understanding of the processes in our companies.
We received elaborated concepts and interlocking processes and were able to benefit from the in-depth knowledge and experience of the tecurat team in the coaching sessions and workshops.
In this way, we were able to significantly develop our process landscape and set the course for further developments and technical documentation according to MDR.
We can recommend tecurat to anyone who wants to build up internal knowledge and implement the process contents according to MDR.
(Translation of German Original)
CARESYNTAX GMBH
Mr Schaumann supported us in preparing for an audit by the authorities and, in the course of this, in revising our technical documentation.It should be positively emphasised that he sets realistic expectations. In the project, he was able to assess his capacities very well throughout and always delivered what was discussed at the agreed times.
This made the cooperation during the entire project very uncomplicated and pleasant.
As a result, we were able to fundamentally revise our entire technical documentation within a very short time and draw a consistent picture of our products.
We thank Mr. Schaumann for his competent support and the good cooperation!
(Translation of German Original)
International german manufacturer of Class III devices
Unlike many other consultants, Mr. Schaumann has taken responsibility and operated as a team member in the project team.He proactively took over the communication with other departments and participants and thus greatly relieved our project team, and adapted to the team structures, depart-ments and processes during the project and delivered all results according to the existing company processes as desired.
Due to his goal-oriented com-mitment, a rethinking process regarding the approach to usability topics has begun in our company.
We are happy to work with him on new usability projects.
We can recommend his support to anyone who is looking for assistance in the implementation of new standards, especially when it comes to the concrete application in their own company.
(Translation of German Original)
German manufacturer of Class III devices
"Hello Sven, we have just received approval for our software much faster than anticipated. We were praised for the good quality of the submitted documentation. You have made a significant contribution to this. Thank you again for your professional support. We really appreciated working with you.“(Translation of German Original)
A multitude of MedTech-companies trust in the expertise of tecurat
We are happy to be there for you
How can we help you?
Contact us.
Meet up with us:
In the office or online – or send us an email whenever you want.
We look forward to meeting you!
Phone
+49 331 600 87 640