Up until the time when I joined the RQS team in November all I had ever truly worked on was Quality. Coming out of college I worked for a plastics bottling manufacturer in process development and quality control. My next job was design V&V closely followed by design quality engineering and risk management. My exposure to regulatory affairs was at an arms length. I was always the person on the other end of a conversation where I was the one being told that I need to do something in a particular way because the regulations said so.

When I left to join RQS my mission statement to the team was I wanted more exposure to regulatory affairs as much as possible to finally be able to understand the regulatory world and hopefully become proficient. My first assignment was to complete a design dossier and I was up to my eyeballs in regulatory literature. But I learned and I persevered. This blog is just to highlight what helped me through this process.

With regards to searching for adverse events I utilized the MAUDE database (http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfmaude/search.cfm), PubMed (http://www.ncbi.nlm.nih.gov/pubmed/), MHRA (http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/index.htm), and Google Scholar (http://scholar.google.com/) just to start. This enabled me to determine what other similar medical devices have experienced in the field.

The other time consuming side of the design dossier was determining what regulations were to be followed and if the most recent version was being utilized. To determine this one can utilize the following two websites: FDA (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm) and EU (http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/index_en.htm). Depending on the intended distribution of the medical device you may need just one of these or both.

Hope this helps whomever decides to take a stroll down the path of regulatory affairs.



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