Quality and Regulatory
Temptime Commitment to Quality
Quality is part of our culture at Temptime. We have developed an integrated quality system based on the requirements of the ISO 9001 Quality System Standard and the FDA’s Quality System Regulations. Our commitment is defined in the three foundations of our Quality Policy:

• Efficient processes 
• Products that consistently meet customer expectations
• Continuous improvement

Our quality system documents all the processes and procedures we follow to develop, manufacture and ship products that meet our customer’s requirements. We welcome the opportunity to have our customers on-site to assess the quality system. It is a very effective way to fulfill all three foundations of our quality policy.

United States FDA
Temptime has received a 510(k) clearance from FDA to market its HEATmarker Time Temperature Indicators as a stand-alone device for use in monitoring medical devices. 

CE Mark
Temptime has established a technical file and signed a Declaration of Conformity for the HEATmarker Time Temperature Indicators.  The company’s authorized representative in the EU, AR-MED, has submitted a Class 1 notification of intent to CE-mark the product to the Medicines and Healthcare Products Regulatory Agency in the UK. The MHRA has accepted our registration of the HEATmarker TTI as a Class I product.

ISO Certifications
The Temptime quality system is certified to the ISO 9001:2008 Quality System Standard and ISO 13485:2003 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.

Customer Audits
Temptime is routinely audited by some of the largest pharmaceutical companies in the world including the vaccine suppliers to the WHO such as GSK, Sanofi Pasteur, Merck and Novartis.

Product Quality Control
All of Temptime's products are manufactured to detailed specifications. Each product lot must meet specification in well controlled release testing.