Cook History
Company Programs
Regulatory Agencies
Quality Management System
100

Began in 1963 with just 3 products and 2 employees.

What is Cook Medical?

100

This project was named after a Superhero.

What is Project Flash?

100

It is responsible for protecting public health by regulating and supervising the safety, efficacy, and quality of food, pharmaceuticals, medical devices, cosmetics, biological products......... and issues 483 letters! :-)

What is FDA?

100

This is the legacy number for the procedure that describes the regulatory affairs activities for obtaining product marketing authorization for Cook Incorporated.

What is QSP15?

200

Established in 1983 and located in West Lafayette.

What is Cook Research, Inc. (CRI)?

200

This project is a remediation initiative for EU and APAC regions.

What is Project ATLAS?

200

It is Australia’s regulatory authority for therapeutic goods, including medicines, medical devices, blood products, and biologicals.

What is TGA?

200

It is a recently introduced software designed to manage submissions and track registrations.

What is RIMS?

300

Bill and Gayle Cook led the extensive and privately funded restoration of this historical landmark in a renowned resort.

What is the West Baden Springs Resort?
300

It is Gene's motto that aligns with our company values.

What is SQDC?

300

This regulatory agency responsible for medical device regulation in China

What is NMPA?

300

Is a quality system form used by Regulatory Affairs to manage and update regulatory restrictions for products in specific countries and territories. This form ensures that product releases and restrictions are accurately tracked and controlled in all markets.

What is the Regulatory Restrictions Control Form?

400

Proximate number of individuals employed by Cook.

What is over 10,000?

400

This program is focus on connecting employees to resources for education and well-being, while also creating opportunities for growth and development.

What is my Cook Pathway?

400
It is Mexico's regulatory authority responsible for overseeing health care-related products and services.

What is COFEPRIS?

400

This audit satisfies the regulatory requirements of Australia, Brazil, Canada, Japan, and the USA.

What is MDSAP?

500

This author wrote the book called "Bill Cook Story: Ready, Fire, Aim.

Who is Bob Hammel?

500

It is a global major program/project designed to modernize business systems, processes, and data, with the aim of increasing operating income, improving resource efficiency, and enhancing customer service.

What is Voyager?

500

The primary regulatory agency for medical devices in Dubai and the rest of the UAE which became the sole federal authority for medical and pharmaceutical products.

What is EDE?

500
It is a standardized system to identify and track medical devices throughout their distribution and use.

What is UDI?