ISO Archives - EMMA International

Recognized Consensus Standards

Under FDA compliance, to bring a medical device to market, there are a multitude of regulations that need to be accounted for and followed. Many of these regulations fall under the Code of Federal Regulations (CFR), however, others are known as recognized consensus standards. These recognized consensus standards are adopted from the International Organization for Standards (ISO), Clinical & Laboratory Standards Institute (CLSI), American Society for Testing and Materials (ASTM), American National Standards Institute (ANSI), Association for the Advancement of Medical Instruments (AAMI), International Electrotechnical Commission (IEC), or other Standards Development Organizations (SDOs). These standards can either be voluntary or required via being ‘incorporated by reference’ into the regulation (CFR) [1].

The Digitalization of Quality Management Systems

One blessing that occurred in the recent years is the rapid digitalization of business functions. It’s hard to imagine a time before the use of video calling or instant messaging to reach teammates or clients from across the world almost immediately.

HIPAA and GDPR’s impact on Medical Devices

The European Union’s General Data Protection Regulation (GDPR), which was put into effect on May 25, 2018, is often considered to be one of world’s toughest laws when it comes to privacy and security. The regulations lay down privacy and security standards, imposing obligations on any/ all organizations having an impact on the people of EU, whether related to targeting or collecting data.

QSR and ISO 13485 Harmonization: Enforcement, the Ultimate Question

A couple of weeks ago I had the pleasure of moderating one of the Food and Drug Law Institute’s (FDLI) Law over Lunch Sessions. I spent my lunch hour with industry folks and lawyers discussing the forthcoming Quality System Regulation and ISO 13485 Harmonization. One topic emerged as the front-runner of what was on everyone’s mind: how is the FDA actually going to conduct enforcement for this? Can we expect to see a major change in FDA enforcement?