tecurat GmbH – Specialists from the industry for the industry
We assist you in product conception and translation of the stakeholder require-ments into design specifications, so that your development leads to a safe medical device.
We check your development documenta-tion for consistency and show you how to structure and format the complex con-tents of the technical documentation in a way that is relevant to approval.
We will demonstrate how to map your develop-ment-related information in a scalable digital lifecycle management system and how to take into account the further development of your products.
Are your employees unsure how extensively to carry out a gate review in the development process?
Would you like to compile your technical documentation in STED format and need assistance?
Is it difficult for you to efficiently document the causality chains of requirements, risks and tests?
Then take advantage of our many years of professional and consulting experience with numerous customers from the MedTech industry and make an appointment with us!
Innovation idea
The idea for the new development of an innova-tive medical device is followed by an intensive phase of requirements analysis and design conception. On top of the documentation of all processes related to the planning and implementation, accompanying risk management is indispensable.
Purpose
We help you to focus on the clinical benefit at an early stage and to get in touch with clinical experts in good time in order to consider and cover all requirements realistically. Merely so, you can to adequately take into account the requirements of the future target group in the design input.
Acting with foresight
We will familiarize you with the regulatory requirements in the early phases of your product development. In this way, we train your eye for the essentials and prevent knowledge deficits and time delays by showing you the importance of the requirements right from the start:
right from the start and put them into practice on your product. Our knowledge covers a wide range of requirement types in the case of complex medicalproducts, consisting of software and hardware functional units.
Documentation obligation
If you systematically plan and carry out your development process, it will be even easier for you to document its progress in accompanying documents of the Device History File & Device Master Record to finally summarize it in the technical documentation.
Agile Implementation
With our extensive experience in the development of software and the associated normative requirements (IEC 62304), we are particularly knowledgeable on the process architecture of agile development processes.
Test phases
The development process is determined by numerous test phases. Next to the accompanying usability tests (ISO 62366), these include specific test procedures. Successful tests verify the respective requirements.
Post-Market surveillance
The development does not end with the production of your medical device. Rather, it is impera-tive that you maintain the successful evolution of your product through appropriate proactive post-market surveillance activities even after market access through suitable risk management. This includes, in particular, the consideration of feedback from the field, as well as a resulting correction and improvement management, which can also lead to the modification of individual product requirements that have already been verified.
Change management
Risk management (ISO 14971) plays a particularly important role in the development process. Within the framework of a solid and reactive change management, it must be ensured that, in addition to all risks assessed in the development process, the hazards that occur after placing on the market within the framework of
be re-registered.
We will show you how to control and document your design inputs and outputs in an appropriate quality management system.
Parallel to your product, we develop adaptive risk management – so that your product remains safe at all times.
We provide support with suitable methods and tools for documentation and process control.
We train and coach the teams involved in development, product management, usability and management across departments and much more.
We advise you on usability aspects from the definition of the intended purpose to formative/summative testing.
Together with you, we design user scenarios and test runs in order to check all requirements efficiently and in compliance with the rules.
We work through the outstanding corrective and improvement measures (CAPAs) and guide them to implementation.
We are happy to be there for you
Meet up with us:
In the office or online – or send us an email whenever you want.
We look forward to meeting you!
+49 331 600 87 640
+49 331 600 87 640
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