We are excited to announce, as of Jan 1, 2018 we are fully ISO 9001:2015 Compliant! Over the last several months we have been working with Core Business Solutions to establish our QMS. Our next step is the stage 1 and stage 2 audits by Perry Johnson Registrars, Inc. We expect to be ISO 9001:2015 Certified by the end of May 2018.
Blazonco just designed our new website, and we couldn't be happier! Blazonco is a full-service web design company
Often overlooked with disastrous results, a weak IFU can result in, at the very least, a failed Summative Validation Study. And more importantly, the FDA and IEC/ISO 62366-1:2015 will not permit medical device manufacturers to mitigate use errors via the IFU. However, a clearly written IFU can help ...