• ISO 13485 quality management for medical devices and IVDs

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Four reasons for our cooperation


  • You benefit from our years of experience in quality management according to ISO 13485.
  • We offer customized solutions for your quality management system.
  • Your project success is ensured by our experts.
  • Your satisfaction is our most important goal.

Our experts provide know-how and hands-on mentality. With thinqbetter you have a partner who takes on tasks as an external service provider for you quickly, easily and reliably.

Our Services

thinqbetter offers various services that can support your quality management system. If you need anything other than the services listed below, please contact us.

Creation of complete QM systems

We create complete QM systems, ready for implementation. Ready for an audit.

Creation of processes

You only need certain processes? We can provide you with all processes related to ISO 13485 that you need.

Takeover of tasks within your QMS

Do you lack personnel or expertise in a specific area of your QMS? We can provide you with an expert.



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Content



General information on Quality Management

Continuous improvement - This is one of the core elements of a quality management system (QMS). In addition, a QMS should ensure that internal processes are controlled and managed. In relation to a process, this means ensuring that the process constantly delivers the output that is expected of it and which is within specified acceptance limits.

For manufacturers in the medical device industry as well as for other players involved in the product life cycle of a medical device, there is ISO 13485, which contains specific aspects that a QMS in the medical device industry must include.

In addition, there is also a general standard that can be applied by all companies - in other words, regardless of the industry. This is the ISO 9001.

For laboratories, for example, there are other applicable QM standards. You will find these further down on the page with a link to the ISO store.


QM in medical devices

As already mentioned, ISO 13485 must be applied for medical devices. This is because medical devices have very specific requirements that must be addressed in a QMS. In addition, the General Safety and Performance Requirements (GSPRs) of the MDR or the Essential Requirements of the MDD must be met.

Compliance with these can be proven by proving compliance with harmonized standards. In such a case the so-called presumption character applies. On this basis, only a specific QM standard is capable of proving the respective requirements of the MDR or MDD.


What influence do MDR/IVDR have?

The requirements that the Medical Device Regulation (MDR) and IVDR place on quality management systems are not fundamentally new. With the compliance to ISO 13485:2016 manufacturers are well positioned. Nevertheless, a gap analysis should be carried out to determine which requirements are not yet completely covered by the respective QMS.

Processes such as post-market surveillance now have extensive requirements at the legal level that must be implemented in the QM system


What are the advantages of MDR/IVDR?

Taking into account all the high demands on manufacturers, new possibilities arise with regard to the further development of targeted processes. Effectiveness and efficiency should therefore be given high priority. Quality management does not only optimize quality-relevant processes. It can have a positive influence on the entire structure within an organization.

Through optimization and solution-oriented approaches thinqbetter creates a basis for your company to benefit from regulatory requirements.


  • ISO 13485 quality management for medical devices and IVDs

    Trust

  • ISO 13485 quality management for medical devices and IVDs

    Customer Satisfaction

  • ISO 13485 quality management for medical devices and IVDs

    Reliability

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