Arwen Consulting provides training in ISO 13485:2016 foundation and internal auditing. This training is provided on an in-company basis only. This training can be fully customised to meet your needs. The ISO 13485:2016 foundation course typically takes one day, with the internal auditing portion covering a second day. This can be delivered in two consecutive sessions, or individual days.
If you do not have sufficient numbers for in-company training, please let us know and we can refer you to reputable training providers.
What is a medical device?
A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.
Who is ISO 13485 for?
ISO 13485 is intended to be utilized by associations engaged with the design, production, installation and servicing medical devices and related administrations. It can likewise be utilized by internal and external parties, for example, certification bodies, to assist them with their auditing processes.
Certification to ISO 13485
Like other ISO administration framework models, certification to ISO 13485 isn’t a prerequisite of the standard, and associations can organizations can reap many benefits from implementing the standard without undergoing the certification process. In any case, third party certification can show to controllers that you have met the necessities of the standard.