Medical Device

 You focus on your business and its products, so let us focus on the regulatory requirements, ISO standards and how to achieve constant audit readiness.


CONSULTING – we provide you with:

  • Assessment and planning all of necessary documentation for your specific industry standards
  • Development of required policies, procedures and support documents for your industry standards
  • Customized QMS development according to ISO 9001/ EN ISO 13485
  • Refinement and maintenance of your QMS to ensure effectiveness, compliance and performance
  • Implementation and training of the QMS


AUDITING – we offer you:

  • Independent system checks for compliance verification
  • Detection of compliance gaps and process inefficiencies
  • Pre-compliance audits / internal audits
  • Audit support and „on demand" support


Choosing Mediantis as your partner means we focus on the details while your associates focus on your business. We perform the majority of the work with focused input from all affected functions to ensure regulatory compliance to build a robust QMS.