Integrated Technologies Ltd has successfully achieved accreditation of ITL Virginia Inc., its wholly owned subsidiary in the United States, to ISO 13485.
Thomas Jull - VP Operations at ITL, Dr. Philip Macarthy from BSI America and Andrew Goodenough - QA/RA Manager at ITL.
The audit was held at ITL Virginia on the 9th and 10th of November 2016 with Dr. Philip Macarthy from BSI America, and was hosted by Thomas Jull VP of Operations and Andrew Goodenough QARA Manager.
The audit at ITL Virginia was successful and covered the full scope of ISO 13485 apart from Design and Development, which is currently only performed in the UK.
This is fantastic news for ITL VA – our goal has always been to provide a domestic contract manufacturing service for our clients in the US. We know this will open up a host of new opportunities and collaborations for us.”
Thomas Jull, ITL VA's Vice President
He added, “We’ve worked very hard to get to this stage and during the visit the auditor, Dr Philip Macarthy expressed sincere compliments on the layout of the work environment and the robust quality system that is currently in place.”
The US arm of medical design and manufacturing company ITL, moved to Richmond, Virginia in May 2013. ITL Virginia has been operating at their current site since November 2014, providing vital US based service and repair hub for existing customers.
The Quality Management System has been followed to the requirements of FDA 21 CFR Part 820 from the very start of operations at ITL VA allowing compliant manufacture of medical devices.
This approval demonstrates an adherence to the development plan for ITL Virginia which is currently supporting a small number of established medical devices. This has allowed for sufficient auditable data to be generated to facilitate a full ISO 13485 audit.
ITL VA operates to the same Quality Management System as the UK Head Office to ensure absolute consistency across the group. Therefore, is easy to set up, run, transfer, support, and monitor medical device projects across the company.
The approval follows the successful three year ISO 13485 re-certification of ITL, made in October, which allows ITL VA to be cleanly added as an additional site.
Thomas Jull, added, “Accreditation to ISO 13485 is an absolute requirement of many of ITL’s customers for subcontract manufacture, and this news allows ITL VA to move forward with two new complex medical devices for both manufacture and service early next year.”
“It also signals valuable opportunities for prospective American customers and UK contacts who are looking to break in to the US medical device market.”