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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.
Global 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:
Learning Level:
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.
Learning Objectives
Upon the webcast's conclusion, you will be able to:
Who should attend?
Speakers
Nicholas Werner, senior scientific advisor, regulatory affairs, Network Partners