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.
Author Archives: Kim Young, Director Global Regulatory Intelligence
Virtual Time Out
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 The need for quality, family holiday time, superseded my weekly and ever scintillating blog writing.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 […]
Reality of Regulatory Reliability
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 […]
Mistakes Cost
August is holiday season for the northern hemisphere regions. Those of you down “under” (Santiago, Cape Town, Sydney, Christchurch) are hopefully enjoying a lovely winter. 😊 Summer holidays in the UK are a very much anticipated annual ritual. Whether one spends the holiday time pootling around the garden, sightseeing locally, visiting friends and family or […]
Regulatory Data Analytics
Regulatory Affairs Analytics Behind every regulatory operations workflow, registration submission, health authority interaction, there lies data ripe for analysis. This data is probably one of the most important resources a life science organisation can possess. Utilising analysis of this regulatory data can help drive change with positive outcomes to support increases in efficiency and revenue […]
Thursday Thoughts: Webinars
Working from home during lockdown does have some advantages. During the past few weeks I have viewed or participated in a number of virtual discussion sessions and educational webinar presentations across different timezones. I do have to say that the quality of the content and level of professionalism has varied widely. Every day, I receive […]
We are Family
Human families come in all shapes, sizes, colours, genders and ages. However; in the case of medical device categorisation, the definition of a “family” of product codes is entirely up to you…
Not Amused
Today I attended a very informative webinar hosted by British Standards Institute (BSI) on their interpretation of the medical device regulation requirements under Article 117 for drug device combination products marketing in the European Union from 26 May 2021. My objective for attendance was to confirm my understanding of the Article and obtain an interpretation […]
Who’s Zoomin’ Who
An optimally engineered and collaborative regulatory operations workplace is not a nice to have, but essential for organisational survival and success.
Article 16 and Then Some
Let’s say I am a medical device importer or distributor and have just begun to think about how to incorporate MDR Article 14 and applicable EUDAMED requirements into my day to day processes, when the regulatory manager at manufacturing company AXV asks me about compliance to MDR Article 16 “Cases in which obligations of manufacturers apply to importers, distributors or other persons”.
