Para Tech meets certification requirements as a qualified vendor with a number of companies across the full range of Parylene applications, based on technical competence, qualified facilities, and years of industry experience. Our process is IPC-CC-830 B and MIL-I-46058C certified as well as RoHS compliant.
Para Tech offers raw material approved per Qualified Product Listing, QPL-46058. This qualification is specified for products under MIL-I-46058 requirements.
ISO13485 – Para Tech has been compliant to the medical standard ISO13485 for many years and taking the next step to become certified in 2019. ISO13485 is a standard specifically designed for the medical industry, and its good manufacturing practices have supported Para Tech on the development of its QMS across sites
ISO9001 – certified in October 2006 and recertified to ISO9001:2008 in 2009. The certification of Para Tech quality management system (QMS) was driven by our strong presence in the Aerospace & Military (A&D) and Medical industries. [Download Certificate PDF]
ISO13485 – Para Tech has been compliant to the medical standard ISO13485 for many years and is taking the next step to become certified by the 1st quarter of 2018. ISO13485 is a standard specifically designed for the medical industry, and its good manufacturing practices have supported Para Tech on the development of its QMS across sites.
AS9100 – Para Tech was the first Parylene conformal coating supplier to be certified to the aerospace standard back in October 2008. The accomplishment increased our high level of quality and the specific requirements set for aerospace and military industries. Recertified initially to AS9100 rev. C in September 2011, the Middletown, CT facility in May 2012 and February 2016, Para Techs 3rd location in Neenah, WI was certified. Para Tech maintains a 3-year certification schedule to stay current with the latest revisions at all coating centers. [Download Certificate PDF]
ITAR – registered in October 2010, the ITAR regulation ensures that sensitive data is protected, especially of being released to foreign persons. PTC has always safeguarded customers’ information and this registration is demonstration of our policies.
MAF – Para Tech obtained a FDA master file for device in September 2011. This FDA record allows our customers to use our process information on premarket approval applications (PMAs), investigational device exemptions (IDEs), premarket notification submissions (510(k)s), reclassification petitions, color additive petitions or other FDA submissions that apply to Parylene coating.
RoHS – Raw materials used for the conformal coating meet the requirements of European Directive 2002/95/EC and are compliant since 2006.
Medical Applications – Para Tech raw materials (Parylenes N and C) comply with USP biological testing requirements for Class VI Plastics. Para Tech Parylene coatings have been successfully tested on medical devices by several customers.
Contact Curtiss-Wright Parylene Services with questions related to Parylene use in industrial and commercial coating applications, or for assistance with process development and full coating services for your products.