Regulations.gov
All of FDA’s regulatory documents, including public correspondence with FDA, is posted to the Regulations.gov website.
Guidance Database
Lists all official FDA Guidance Documents and other regulatory guidance.
The Society of Clinical Research Associates, Inc. (SOCRA)
Provides education, certification, and networking opportunities to all persons involved in clinical research activities.
American Society for Quality (ASQ)
A knowledge-based global community of quality professionals to promote the use of techniques to improve organizational quality.
Regulatory Affairs Professionals Society (RAPS)
RAPS is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.
International Organization for Standardization
ISO creates documents that provide requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.
Medical Device Registration
Most recent version of the MDR along with supporting guidances.
21 CFR Part 820
Most up to date version of CFR – Code of Federal Regulations Title 21 Part 820 Quality System Regulation.
