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].
ISO
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?
Why More Companies Should Participate in VCRP
The FDA regulates a wide range of manufactured goods for consumers, including food, electronics, medications,...
QMS Tips
Every organization that manufactures medical devices, pharmaceuticals, biologics, cosmetics, or other types of...
The Role of CMO’s in Life Sciences Manufacturing
Navigating ever-changing markets and supply chains has been challenging for many companies in the ongoing...
Pop Healthcare
For a long time, healthcare was in the hands of doctors. People listened only to their doctor’s advice on how...
Importance of Document Control on a Quality Management System
In highly regulated industries, document control is among the most necessary means for compliance. A document...
Differences Between ISO 13485:2016 and 21 CFR 820
Regulations ensure medical device manufacturers produce consistent safe products. A well-structured...
The Flu in 2021
With Halloween behind us, the most wonderful time of year is almost here, flu season! The COVID pandemic set a...
Devices in the Digital Age
As the digital age continues to advance at an amazing pace, healthcare and medical devices have managed to...
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