This Certificate is Applicable to
Business processes: Collecting, defining and managing requirements. Planning, designing, researching, developing, collaborating, implementing, manufacturing, documenting, verifying and quality assuring and hosting products. Submitting products for the American Food and Drug Administration (FDA) approval. Marketing, selling, consulting on, deploying and integrating products.
System/products: Clinical trials, medical devices, platforms, services, software and systems - either on-premises, mobile or in the Cloud (e.g. SaaS).
According to Statement of Applicability: Version 1.0, Date: February 4th 2018