Diversionary Therapy Technologies is dedicated to ensuring that our products exceed all international standards in safety, design and quality. For this reason, we have created a Regulatory Compliance page, which will help you to quickly and easily understand the certificates, approvals and compliance information for DTT's products.
Quality Management System Compliance
US FDA Good Manufacturing Practice (GMP)
21 CFR 820: US FDA Quality Systems Regulations
We are fully compliant with 21 CFR Part 820.
ISO 13485: Quality Management System for the Design and Manufacture of Medical Devices
DTT Quality Systems are designed and maintained to comply with the requirements of international harmonised standard ISO 13485.
Product Certifications and Approvals
Australia:
Devices listed in ARTG
ditto™ Portable Console
Declaration of Conformity
ditto™ Portable Console
Global Regulatory Representatives
Emergo Group
http://www.EmergoGroup.com
Australia:
201 Sussex Street
Darling Park, Tower II, Level 20
Sydney, NSW 2000 Australia
Phone: +61 (0) 2.9006.1662
Fax: +61 (0) 2.9006.1010 |
United States:
611 West 5th Street
Third Floor
Austin, Texas 78701 USA
Phone: +1.512.327.9997
Fax: +1.512.327.9998 |
Europe:
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: +31.70.345.8570
Fax: +31.70.346.7299 |
Material Data Safety Sheets
Product Patents
Patent for 'diversionary therapy apparatus and methods and interactive devices'- China 200680042383.2
Patents for the following countries/regions are pending:
Australia | United States | Europe | Malaysia | New Zealand | Japan | Canada | Hong Kong
Regulatory Compliance
The ditto™ device and accessories are tested and conform to the requirements of IEC 60601-1: Medical Electrical Equipment- General Requirements for Basic Safety and Essential Performance.
Risk Based Classification Category
Class I (Low risk)