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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an On-demand
recording from February 2019.
This webcast is device
focused and is only intended to be applicable to the medical device sector.
regulatory submissions are becoming increasingly more stringent related to
cybersecurity requirements. One
consistent expectation is that manufacturers provide evidence of effective
cybersecurity risk management. Being
able to interpret what countries are expecting and how they leverage
cybersecurity risk management is becoming critical for successful
submissions. It is also imperative to
understand that safety risk management alone is insufficient for cybersecurity
risk management. This webinar will focus
on three aspects:
Intermediate: Content is designed based upon the assumption that individuals
have basic knowledge of the topic(s) and/or demonstrated
competence related to the topic(s). Higher-level concepts are
introduced during lectures; exercises requiring synthesis and/or application of
concepts are incorporated into the activity.
Upon the webcast's conclusion, you will be able
Nicholas Werner, senior scientific
advisor, regulatory affairs, Network Partners