Quality

Since 1999, Therapak has been earning the respect and trust of its customers with a harmonized Global Quality Management System (QMS) which is reviewed during internal audits and customer audits. Therapak has four strategically positioned facilities in Los Angeles, Atlanta, London and Singapore to offer our customers a reliable and compliant environment for supply management & distribution solutions with a built-in Business Continuity Plan. Therapak’s regulatory certifications are identified below:

LocationCertificationReference No.
All US facilitiesFood and Drug Administration Department of Health and Human Services, Public Health Service, Owner/Operator9002081
Duarte, CAFood and Drug Administration Department of Health and Human Services, Public Health Service, Registered Establishment2027968
Duarte, CAState of California Department of Health Services, Food and Drug Branch, Device Manufacturer License50941
Buford, GAFood and Drug Administration Department of Health and Human Services, Public Health Service, Registered Establishment3006450277
London, UKDepartment of Health, Medicines and Healthcare Products Regulatory AgencyCA 009316
SingaporeUnique Entity Number (UEN)201112968M
SingaporeHealth Sciences Authority, Medical Device Dealer's Licence (Registrant)ES0002708
SingaporeHealth Sciences Authority, Medical Device Dealer's Licence (Importer)ES0002357
SingaporeHealth Sciences Authority, Medical Device Dealer's Licence (Wholesaler)ES0002523
SingaporeGood Distribution Practice for Medical Devices (GDPMDS), TÜV SUD PSB Pte. Ltd.GDP-2012-0102
SingaporeAVA Registration to Import Processed Food Products and Food AppliancesIP13M0178

Therapak Quality Policy

It is our policy to consistently deliver products and services that fully meet Customer specifications, company policies and procedures and regulatory requirements for the assembly and distribution of medical devices, convenience kits and procedure packs. Therapak will ensure our Client's confidence by remaining current with supply chain developments, optimizing training methods, monitoring key quality performance metrics and continually improving our processes and services as part of an effective Quality Management System.

Quality Assurance

Therapak's Quality Management System has been developed in compliance with regulatory standards to meet the needs of our global customer base and to improve the management practices of our company. The quality system operates in accordance to the United States Food and Drug Administration's current Good Manufacturing Practices for medical devices - 21 CFR § 820; Singapore HSA's TS-01 - Good Distribution Practices for Medical Devices and Good Assembly Practices; and Article 12 of Council Directive 93/42/EEC concerning medical devices, commonly referred to as the Medical Device Directive (MDD).