TechTrade LLC Achieves ISO 13485 Certification

TechTrade LLC, manufacturer of the Ready-Heat Disposable Medical Heated Blanket, has achieved ISO 13485 certification as part of its effort to begin marketing its portable heated blankets for treatment of trauma and hypothermia in Europe.

The ISO 13485 certification process took five months to complete and was achieved with assistance from Emergo Group, an ISO 13485 consulting firm serving the medical device industry. TechTrade had previously obtained ISO 9001 certification for a separate product, and the two companies were able to build on that work to implement an ISO 13485-compliant quality system.

With an ISO 13485-compliant quality system in place, TechTrade is now one major step closer to obtaining the CE Marking necessary for commercialization in Europe. Emergo Group will then serve as the European Authorized Representative of the Ready-Heat blanket once it has been approved for sale.

TechTrade’s current clients include the US military, which carried out clinical trials of the Ready-Heat product, as well as emergency response providers and hospital groups.

“With Emergo Group it was a hand-in-hand process,” says Andrew Shapiro, product development manager at TechTrade. “Emergo Group handled the soup-to-nuts issues in terms of keeping us informed, and helped us leverage our previous ISO 9001 work since there’s some overlap there with 13485. They proved highly responsive before, during and after the process.”

“ISO 13485 certification is a crucial element of a medical device manufacturer’s CE Marking process,” says Emergo Group Vice President of Quality Assurance Consulting Richard Vincins. “With an ISO 13485-compliant quality management system now in place, TechTrade LLC has made significant progress in its effort to enter the European medical device market.”