Compliance GlossaryA reference guide to certifications, registrations, and quality systems supported by Global Business Development, LLC.
Medical Device CertificationsFDA 510(k)
Premarket notification required for most Class II medical devices sold in the U.S. Demonstrates “substantial equivalence” to an approved product.
CE Mark / EU MDR
Certification to sell medical devices in the European Union. Requires compliance with the Medical Device Regulation (EU 2017/745) including a technical file and clinical evaluation.
Health Canada Licensing
Medical device registration process in Canada. Class II+ devices must comply with Canadian Medical Device Regulations and ISO 13485.
TGA (Australia)
The Therapeutic Goods Administration requires registration for devices in Australia, often using EU documentation for mutual recognition.
ANVISA (Brazil)
Brazil’s health authority. Requires technical dossiers and sometimes local clinical data for medical device approval.
UKCA Mark
The UK Conformity Assessed (UKCA) mark replaces CE marking for goods sold in Great Britain. Similar requirements but managed independently post-Brexit.
Technical DocumentationTechnical File
A comprehensive document used in EU and UK approvals. Includes device description, labeling, design verification, clinical evaluation, and PMS (Post-Market Surveillance).
Design History File (DHF)
FDA-required documentation showing the design and development history of a medical device.
Device Master Record (DMR)
A detailed file containing manufacturing specifications, drawings, procedures, and quality assurance requirements for a device.
Unique Device Identification (UDI) / GUDID
A traceability system for medical devices. GUDID is the FDA’s Global Unique Device Identification Database where device info is submitted.
International StandardsISO 13485
The international QMS (Quality Management System) standard for medical device manufacturers.
ISO 14971
Standard for medical device risk management — required in most global markets.
ISO 10993
Biological evaluation of medical devices — required for devices that come in contact with the human body.
MDSAP (Medical Device Single Audit Program)
A global audit program accepted by the U.S., Canada, Brazil, Australia, and Japan that streamlines inspections into a single process.
Government Contracting & Facility ComplianceSAM.gov / UEI / DUNS
Registrations required to do business with the U.S. government. All must be kept current and reflect correct legal address and facility info.
Nexus Evaluation
A legal and tax assessment to determine where a business has obligations based on office location, remote employees, or warehouse operations.
Remote Warehouse Certification
Ensures fulfillment centers and satellite locations meet U.S. federal requirements (e.g., FAR/DFARS, ITAR if applicable).
Medical Device CertificationsFDA 510(k)
Premarket notification required for most Class II medical devices sold in the U.S. Demonstrates “substantial equivalence” to an approved product.
CE Mark / EU MDR
Certification to sell medical devices in the European Union. Requires compliance with the Medical Device Regulation (EU 2017/745) including a technical file and clinical evaluation.
Health Canada Licensing
Medical device registration process in Canada. Class II+ devices must comply with Canadian Medical Device Regulations and ISO 13485.
TGA (Australia)
The Therapeutic Goods Administration requires registration for devices in Australia, often using EU documentation for mutual recognition.
ANVISA (Brazil)
Brazil’s health authority. Requires technical dossiers and sometimes local clinical data for medical device approval.
UKCA Mark
The UK Conformity Assessed (UKCA) mark replaces CE marking for goods sold in Great Britain. Similar requirements but managed independently post-Brexit.
Technical DocumentationTechnical File
A comprehensive document used in EU and UK approvals. Includes device description, labeling, design verification, clinical evaluation, and PMS (Post-Market Surveillance).
Design History File (DHF)
FDA-required documentation showing the design and development history of a medical device.
Device Master Record (DMR)
A detailed file containing manufacturing specifications, drawings, procedures, and quality assurance requirements for a device.
Unique Device Identification (UDI) / GUDID
A traceability system for medical devices. GUDID is the FDA’s Global Unique Device Identification Database where device info is submitted.
International StandardsISO 13485
The international QMS (Quality Management System) standard for medical device manufacturers.
ISO 14971
Standard for medical device risk management — required in most global markets.
ISO 10993
Biological evaluation of medical devices — required for devices that come in contact with the human body.
MDSAP (Medical Device Single Audit Program)
A global audit program accepted by the U.S., Canada, Brazil, Australia, and Japan that streamlines inspections into a single process.
Government Contracting & Facility ComplianceSAM.gov / UEI / DUNS
Registrations required to do business with the U.S. government. All must be kept current and reflect correct legal address and facility info.
Nexus Evaluation
A legal and tax assessment to determine where a business has obligations based on office location, remote employees, or warehouse operations.
Remote Warehouse Certification
Ensures fulfillment centers and satellite locations meet U.S. federal requirements (e.g., FAR/DFARS, ITAR if applicable).
