We fully manage the certification of ISO 13485.
We carry out internal audits against your system.
We provide training in ISO 13485 foundation.
We compare you to the
required ISO standards.
We are passionate about compliance on two fronts – complying with standards and medical device regulations
such as ISO 13485 and the EU Directives, and complying with the needs of our clients.
And we do this on time and within budget, because your success equals our success.