Medical Device Regulated Business

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are: Establishment registration, Medical Device Listing, Premarket...

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

To find the classification of your device, as well as whether any exemptions may exist, you need to find the regulation number that is the classification regulation for your device.

Compliance with Medical Device Regulatory Changes

https://www2.deloitte.com/us/en/pages/advisory/articles/medical-technology-regulation-change-implications.html

New or updated medical device regulations—from the International Organization for Standardization (ISO), the European Union, and a group of nations that have adopted …

The Role of Regulatory Affairs in the Medical Device …

https://www.northeastern.edu/graduate/blog/regulatory-affairs-in-medical-device-industry/

The Regulatory Landscape for Medical Devices | Assent

https://www.assent.com/blog/how-are-medical-devices-regulated/

Medical Device Regulation in Europe On May 26, 2021, the European Union (EU) Medical Device Regulation (MDR) and In-Vitro Medical Device Regulation (IVDR) …

The Medical Device Regulation (“MDR”) - FTI Consulting

https://www.fticonsulting.com/emea/insights/articles/medical-devices-regulation-mdr

The Medical Device Regulation (“MDR”) is a new set of regulations that govern the manufacturing and distribution of medical devices in Europe, and …

An Overview of FDA Regulations for Medical Devices

https://www.einfochips.com/blog/an-overview-of-fda-regulations-for-medical-devices/

Medical Device Regulations in the USA In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for …

Medical Device Regulatory Training Requirements for …

https://www.orielstat.com/blog/medical-device-regulatory-training-requirements/

We would like to emphasize that employees performing functions within the realm of the Quality System Regulations for medical devices must be trained as such and that documentation of that training …

Medical Device Regulatory Strategy for US & EU …

https://decomplix.com/medical-device-regulatory-strategy-us-eu-part-i/

In brief, your regulatory strategy for a medical device to be launched in the US and EU needs to account for potentially significant regulatory differences in: device qualification, device classification, …

Laws and Rules - Medical Device Manufacturers and …

https://www.dshs.texas.gov/medical-device-manufacturers-distributors/laws-rules-medical-device-manufacturers-distributors

Laws and Rules - Medical Device Manufacturers and Distributors Texas Laws Texas Health and Safety Code - Chapter 431, Texas Food, Drug, and Cosmetic Act Rules and …