ISO 13485 consultation

 

The DIN EN ISO 13485 is a standard quality management norm for medical devices.

With the complete consultation, we undertake all necessary tasks for the preparation of a quality management system for medical devices according to ISO 13485. We undertake the complete preparation of documentation, ensure the certifiability of the quality management system and provide you with the greatest possible ease of burden for you. We identify all relevant processes together with you, create the necessary documents (for example process instructions or else) and ensure that the certificate can be „put up on the wall“ within the timeframe agreed-upon.

 

Our services as ISO 13485 consultants:

  • Preparing documentation according to ISO 13485 (quality management manual, process instructions etc.)
  • Determining the processes and documentation in process instructions relevant to quality and standards
  • Implementing the internal audit and the management review
  • Obtaining offers from certification companies accredited by DAkkS and support in the decision making process
  • Assistance in implementing the external audit
  • Consultation and provision of guidance with applications for subsidies

 

Your advantages with Lösungsfabrik:

  • Greatest possible ease of burden - By preparing the complete ISO 13485 documentation, we save you as much work as possible. You only need to provide us with the necessary information (for example in meetings) and can concentrate on your core business and competency otherwise.
  • Streamlined, efficient and sensible - The ISO 13485 is kept very general or can be interpreted generally. We make sure that the necessary documentation is kept streamlined and efficient thanks to our many years of experience in the area of quality management systems. We simply use common sense to interpret the norm.
  • Help selecting the certifiers - We have good contacts to different certification companies thanks to our activities. We obtain different offers for you and support you in selecting a certifier.
  • Assistance with external ISO 13485 audits - After implementing the management system, a certification audit follows generally. Of course we support you with that as well. In our opinion, our consultation activity is finished only after you have received the certificate.
  • Subsidies - You’re possibly eligible to receive subsidies. We undertake research to determine if that is the case and, if so, support you during the application process.
  • Experience - The Lösungsfabrik Thode and Partner possesses more than six years of experience in implementing and managing quality management systems. Until now, every customer of ours has passed their certification or monitoring audits.
  • Good price/performance ratio

 

Do you have questions or want to obtain an offer? You can call us, write us an email or use our contact form.

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