West Lafayette, Ind. — The FDA has reviewed the applications to the Accreditation Scheme for Conformity Assessment (ASCA) Pilot program and has granted laboratory safety accreditation to Cook Research Incorporated (CRI), a part of Cook Medical. CRI is the nonclinical testing and clinical affairs organization supporting Cook Medical products since 1983. This FDA designation is a statement of confidence in the testing conducted to assess performance and safety of the medical devices. With this accreditation, companies like CRI can increase consistency and predictability across its program because the testing has already demonstrated compliance to the technical standards.
The ASCA program, designed by FDA with input from numerous stakeholders recognizes laboratories that perform testing on medical devices. In order 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 CRI has been granted this designation through the Basic Safety arm of the program. The FDA has included CRI on a list of ASCA-accredited medical device laboratories identify the scope of testing and expiration of the accreditation.
“This accreditation is a landmark both for patients and for Cook,” said Jennifer Kerr, president of CRI. “Becoming an ASCA-accredited test lab is an acceptance of nonclinical medical device testing because we have demonstrated through this program that we can provide consistently high-quality and scientifically sound testing methodology and outcomes. We can continue our testing knowing we can collectively get devices to patients more efficiently.”
Located in West Lafayette, Indiana, CRI includes approximately 200 employees who support Cook Medical’s preclinical and clinical activities. We are appreciative of their hard work and dedication to patient safety to receive this accreditation.
About Cook Medical
Since 1963, Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently. We have always remained family owned so that we have the freedom to focus on what we care about: our patients, our employees, and our communities. Find out more at CookMedical.com, and for the latest news, follow us on Twitter, Facebook and LinkedIn.