tecurat GmbH – Experts of the industry for the industry
Adapted to requirements & lean
We check your process design for efficiency and adapt your QM documentation to the existing structures – digitally too.
Lived & accepted
We sensitize employees & partners to quality-relevant work processes in the company and thus create a QM awareness.
Then contact us about the qualitymanagement system of your company and Make an appointment!
The internationally valid standard ISO 13485 is the central guideline for you as a manufacturer for setting up a quality management system for the life cycle of your medical device.
For the European Economic Area, according to EU legislation 2017/745 MDR, every medical device manufacturer must comply with the risk-based requirements of the standard.
The following overarching topics must be taken into account:
These will be implemented under the direction of a QMB (Quality Management Officer) with the involvement of the company’s internal quality management department.
Depending on the risk classification of your product, a conformity check must be demonstrably carried out by you as a manufacturer (Class I products) or a notified body (Class II a/b & III products).
In order to maintain the quality of your medical device, all employees & external parties must know their respective duties and areas of re-sponsibility and implement them conscientiously and quality-conscious.
Only then you are able to provide a medical device on the market that meets the basic safety and performance requirements of the respective legislation and adds value to the patient.
We actively support you on the way to successful QM certification and work with you to create a process-optimized and needs-based QM system. We do not work with ready-made templates, but show you how you can use cross-departmental information units efficiently in order to save resources sustainably.
We actively support you on the way to successful QM certification and work with you to create a process-optimized and needs-based QM system. We do not work with ready-made templates, but show you how you can use cross-departmental information units efficiently in order to save resources sustainably. Resource efficiency through digitalization Discover with us the advantages of digital eQMS documentation management. Use formal & content-related overlaps of information units to automate your process structures through a data-base-driven document management system. This not only saves you valuable time in day-to-day business, but also convinces in the authority audit by providing information quickly.
when your QM system is in focus.
The quality management manual defines the quality objectives of the manufacturing company and illuminates the life cycle of the medical de-vice in a focused manner, including all quality-relevant processes. The elaboration of the QMH must be kept accessible and visible to all employees at all times.
With an outside view, we support you in formulating your QMH into a quickly comprehensible quality reference work for employees and responsible authorities.
Articles on the topic of quality management
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