Information for today’s Regulatory Professional
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If an organisation is still asking basic questions today, at 233 days (5352 hours) until application of MDR, when will they actually be prepared??
European Regulatory requirements1DISTRIBUTORS of medical devices or in vitro diagnostic devices have specific obligations to fulfil under Article 14 of both the MDR and IVDR.2,3 Distributors will have to verify whether: the device has the (CE) mark and an EU Declaration of Conformity has been issued; the importer’s name is affixed on each device or is […]
How many of you have initiated contact with someone you haven’t met (in person) as you struggled to answer a challenging internal query? During this period of lockdown and working from home, I have found myself reaching for my contact lists, both internal and external, more often than in previous months.
Apologies to everyone for the lack of RIMtelligence blog traffic over the last few weeks. The need for quality, family holiday time, superseded my weekly and ever scintillating blog writing. Even with all of the various restrictions, the holiday was absolutely fantastic, (in spite of my breaking one toe on each foot the day before […]
A Regulatory professional’s role in the life-science industry demands a special adherence to a code of ethics. Regulatory Compliance Competency Objectivity Integrity Honesty/Credibility Accountability Equitability Dignity and Respect Our employers, employees, peers, and all external parties with whom we interact, not only expect compliance with these ethical codes, but also rely on our competent guidance […]