The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.
MDSAP is based on ISO 9001:2015 so the following aspects are not covered in the ISO 13485:2016:
Context of the manufacturer
Business risk assessment
What are more differences between ISO 9001:2015 and ISO 13485:2016 you can see on the following link: