Industry Guidance
Relationships That Matter
We continually work with a broad range of industry leaders to ensure Engisystems - and our clients - are on the forefront of knowledge and innovation. Take a minute to visit the following resources for a better understanding of our industry and the challenges ahead.
U.S. Food and Drug Administration - General
FDA Centers and Offices
Drugs
Medical Devices
Biologics
Radiation emitting products
Combination Products
FDA guidance documents
Industry Associations
Drugs
Food and Drug Law Institute
PhRMA
Medical Devices
AAMI – Association for the Advancement of Medical Instrumentation
AvaMed
Device Link List
Medical Device Manufacturers Association
Biotech
BIO – Biotechnology Industry Organization
BIO.com
BIOCOM.org
International Biopharmaceutical Association
Radiation emitting products
Other Government and Notified Bodies
Europe
EMEA – European Medicines Agency
England
MHRA – Medicines and Healthcare Products Regulatory Agency
Japan
Ministry of Health Labour and Welfare
Australia
Strategic Alliances
http://asq.org/
http://www.sei.cmu.edu/
http://www.iso.org For ISO 13485
http://www.fda.gov/
http://www.ieee.org/index.html
http://www.iec.ch/ For IEC 16085 and 62304
http://www.ispe.org/ GAMP
http://www.va.gov/ service disabled Veteran owned
http://www.medicaldevices.org/