Certifications

Credentialed, qualified expertise.

Cook Research embraces quality as a core belief and a company-wide business principle, and our Quality System provides the foundation for delivering services. We maintain certification to ISO 13485, accreditation to ISO 17025 and the FDA ASCA Program, and are inspected to ISO 14155. Further, Cook Research is certified to and in compliance with Privacy Shield for the transfer of personal information from Europe.

Accreditation Scheme for Conformity Assessment (ASCA)

The ASCA program, designed by FDA with input from numerous stakeholders, recognizes laboratories that perform testing on medical devices. To receive this accreditation, laboratories must meet or exceed international conformity assessment standards as well as a set of FDA-identified ASCA program specifications.

There are multiple arms of the ASCA, and Cook Research Incorporated has been granted this designation through the Basic Safety arm of the program. The FDA has included Cook Research Incorporated on a list of ASCA-accredited medical device laboratories identifying the scope of testing and expiration of the accreditation.

EU-US Data Privacy Framework

As further described in Cook Group Incorporated’s Data Privacy Framework Notice, certain companies in the Cook Group have certified to and comply with the EU-U.S. Data Privacy Framework as set forth by the U.S. Department of Commerce regarding the collection, use, and retention of personal information transferred from the European Union and/or the United Kingdom to the United States. The Data Privacy Framework principles are: Notice; Choice (Consent); Accountability for Onward Transfer; Security; Data Integrity and Purpose Limitation; Access; and Recourse, Enforcement and Liability.

For more information on the E.U.-U.S. Data Privacy Framework or to view our certification, please visit www.dataprivacyframework.gov.