Quality
This independent, non-governmental organization develops standards to ensure the quality, safety and efficiency of products, services and systems.
What is ISO?
This US agency is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, pharmaceutical drugs, vaccines, medical devices, electromagnetic radiation-emitting devices, and veterinary products.
What is FDA?
CAPA is an acronym for this process.
What is Corrective Action and Preventive Action?
These are the 3 main instruments manufactured by GSD.
What are Bolt, ThunderBolt and AIX1000?
GSD is the subsidiary of this international company.
What is Eurofins?
GSD internal audits occur at least this often.
What is yearly?
GSD’s assay kits fall under two classes as defined by the FDA.
What are Class I and II?
These are the two main quality system documents.
What are QSP and SOP?
These are the two costumes John wore to the 2022 Cornhole Tournament.
Who are Hagrid and the Grinch?
This is the first product GSD launched.
What is the ThunderBolt?
This part of the US Code of Federal Regulations ensures that all medical devices are safe and follow satisfactory quality processes at all stages of development.
What is 21 CFR Part 820?
This is the four-letter abbreviation commonly used for the regulation entitled "Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU".
What is IVDR?
NCR stands for this form of documentation.
What is Nonconformance Report?
These are GSD’s two current founding employees.
Who are John and Jennifer?
These are the two 2022 Cornhole Champions.
Who are Jacob Roach and Rajveer Aujla?
These are the three elements of a complaint training binder.
What are employee resume, job description and completed training matrix/training records?
This FDA Center is responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices.
What is Center for Devices and Radiological Health (CDRH)?
This is the acronym for GSD’s document change form.
What is DACF?
The year GSD was founded.
When is 2006?
This was the first 510(k) granted to GSD.
What are H pylori IgG and IgA assays?
This international standard establishes the requirements for quality management systems for medical devices.
What is ISO 13485?
FDA is part of this governmental department.
What is the Department of Health and Human Services (HHS)?
SCAR stands for this form of documentation.
What is Supplier Corrective Action Request?
The original GSD logo was this symbol.
What is the alchemy symbol for gold?
This is GSD’s Authorized Representative in the EU.
What is Emergo?