In learning more on the FDA website about design controls, I found the International Medical Device Regulators Forum, which is a global approach to monitoring the manufacturing of medical devices in order to improve their safety and oversight at an international level. They have developed specific documents for advancing a Medical Device Single Audit Program (MDASAP). As stated on the FDA website- the MDSAP allows an MDSAP recognized Auditing Organization “to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program;

International participants include:
Therapeutics Goods Administration of Australia
Brazil’s Agencia Nacional de Vigilancia Sanitaria
Health Canada
Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Device Agency
The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the EU are Official Observers

From Jan 2014-Dec2016 FDA and International partners participated in the MDSAP pilot. In June 2017 they determined that the MDSAP pilot had “satisfactorily demonstrated the viability of the MDSAP” Overall it will be interesting to see how this MDSAP audit reports will substitute routine agency inspections.
https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/