Standards
fully managed.

You can stop worrying about deadlines, scheduling the right team, endless reporting activities, keeping up with accreditation rules, and increasing costs due to complexity. We do it for you!

MDR

Medical devices manufactured or traded in the EU must comply with EU legislation in the area of safety and health. This means they have to be conform to the pertaining product directives and must be CE marked. New European legislation, the Medical Device Regulation (MDR), has taken effect per May 2021. The EU adopted the MDR following scandals caused by a number of medical device manufacturers.

This standard is fully managed by Zertic. From setting the right scoping in the quote to managing deadlines for each audit, nc and certificates. Your audit plan is automatically generated containing all information based on quote, planning, previous audit and provided documents. All relevant reports types are generated just by a push of a button in your format.

Project Details

Categories:

You will get the following right from the start:

  • Quoting and price calculation
  • Timely planning audits
  • Automatic generation of questionnaire
  • Standard reports
  • Client portal for all audit information
  • Client portal for following up NC’s
  • Automatic generation of Certificate
  • Multi-lengual standard
  • Review flow
  • Managed competencies

W I T H   Z E R T I C   S C H E M E S

Manage Costs

Manage Competences

Manage Deadlines

Find out how Zertic can reduce your overhead,
manage deadlines and improve your quality.