Reference

Zi-Medical

A Company Introduction

2018

Case Study: Regulatory Assessment SaMD U.S., EU

2020

FDA Device Recalls

2019

GDPR Regulation PDF

2017

California Consumer Privacy Act

2018

Closing the Gap

Understanding the Software 510K Review Process

2016

ASEAN Medical Device Directive

2015

NIST Contingency Planning Guide

2010

NIST Framework for Improving Critical Infrastructure Cybersecurity

2018

Sample Business Associate Agreement

2018

ESIGN Commerce Act

2000

FDA Q-Sub / Pre-Sub Guidance

2018