Regulatory Hosting

For those customers not being interested or qualified for the implementation of a certifies quality management systems and/or the interaction with a Notified Body AC Aircontrols offers to step in order to become the ´legal´ manufacturer on behalf of the specification developer or IP owner. AC Aircontrols will host the product as being one of its own products under full quality, legal and regulatory requirements including all post market surveillance (PMS) and post market clinical follow up (PMCF) procedures.

This service can only be offered to products being within the scope of AC Aircontrols’ Notified Body and the quality regime and expertise of AC Aircontrols. Risk class III products would be excluded. A detailed and comprehensive contractual setup would be needed prior to a hosting execution to define roles and responsibilities and documentation availability and updates to documents on the manufacture as well as the distributor side.

AC Aircontrols offers to become the manufacturer according to article 2 (30) MDR to 3rd party organizations:

• CE conformity assessment
• Manufacturing, testing and shipment to distributor
• Post market surveillance, vigilance and market surveillance

AC Aircontrols offers to become the authorized representative according to article 2 (32) to 3rd party organizations:

As long as the product will be within the scope of AC Aircontrols´ Notified Body and the product DMR got developed by or shared with AC Aircontrols.