Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
Keep the sparks coming! Delegates of the conference have access to on-demand content until the end of October 2021.
This updated edition is a great reference for anyone working in multinational product development and marketing.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 16 September 2014 | By Stewart Eisenhart,
Content provided by Emergo Group, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.
The European Association for Medical Devices of Notified Bodies (Team-NB) has published an updated Code of Conduct targeting more consistent and transparent CE Mark certifications from member firms.
First implemented by Team-NB in early 2013, the Code of Conduct’s version 3.2 makes more explicit processes and procedures Notified Bodies should follow during CE Marking audits and certifications; another update, version 4.0, is already planned for the near future.
Among the changes in version 3.2 of the code are requirements for compliance with specific EU Medical Device Directive mandates rather than core principles; adjusted frequency requirements for unannounced audits of high-risk devices; and changes to sampling requirements of technical file reviews to apply only to Class IIa and IIb devices.
Team-NB describes these changes as minor, but also indicates more important issues to be addressed in version 4.0 of the code, including minimum review timeframes for technical files, auditor qualifications and developing criteria for technical reviews and training.
Following implementation of the Code of Conduct, European medical device market observers and participants questioned whether new requirements would shake up the Notified Body sector.
According to information Team-NB included in its announcement of the code’s latest version, there has been a slight drop in the number of the association’s members since 2012. Since plans for the Code of Conduct were first announced, Team-NB membership fell from 35 in 2012 to 29 in 2013; that number fell again to 26 in 2014.
(Emergo Group)
Tags: Emergo Group, CE Mark, European Association for Medical Devices of Notified Bodies
Regulatory Focus newsletters
All the biggest regulatory news and happenings.