Commitment to Pharmaceutical Level Quality

Pharmaceutical quality at the GMP (good manufacturing practices) level is part of our culture. All of our indicators are developed and manufactured in strict conformity to our high level quality system. Temptime has received FDA 510(k) clearance for its HEATmarker device, and operates under a GMP quality system certified to ISO 9001: 2008 and ISO 13485 (medical device) standards.

Scientifically Proven and Patented Technologies
We employ our patented scientific technologies and proprietary manufacturing processes to produce the highest quality devices to monitor individual units, multiple unit secondary packages, and shipping boxes of medical products for:

• Cumulative heat exposure (mean kinetic temperature)
• Heat excursions (with a time delay or instantaneous) and/or
• Freeze events 

The Temptime team of PhDs, engineers and technical support staff are committed to new product development and continuous quality improvement.