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Health Canada Announces the Creation of a New Medical Devices Directorate

Health Canada Announces the Creation of a New Medical Devices Directorate

by Jennifer P | Dec 18, 2019 | Canadian Regulatory, Medical Devices, Research/Science/Technology, Uncategorized

Health Canada has announced the creation of a new Medical Devices Directorate (MDD). This was done in order to account for and accurately reflect the current medical device industry, which has evolved drastically over the past several years. The new Directorate will...

Wearable Artificial Kidney (WAK) – A Portable Dialysis Device

by Jennifer P | Apr 3, 2019 | Medical Devices, U.S. Regulatory

Most dialysis patients are presented with limited options for having a great quality of life. The quality diminishes further when they must consume 20-30 pills a day and have to put a harsh cap on their amount of fluid intake. Due to kidney dysfunction, they are in...

Reclassification of High-Level Disinfectants and Sterilant Solutions as Class II Medical Devices

by Jennifer P | Mar 26, 2019 | Canadian Regulatory, Medical Devices

Health Canada issued a notice on March 18th, 2018 regarding changes to classification of high-level disinfectant and sterilant solutions intended for use on medical devices. Instead of being regulated by the Food and Drug Regulations (FDR), disinfectants and...

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    Delsie Braganza

    Delsie joined the Focal Point Research team in 2011 and has been an invaluable asset for our clients. With her strong regulatory and quality assurance background, she is able to audit facilities, set up and maintain GMP compliant facilities, develop strong quality management systems, and co-ordinate successful Health Canada inspections. In addition to this, Delsie oversees all submissions made to Health Canada and the US FDA.

    Delsie obtained an Honours Bachelor of Science (Hons. B. Sc.) in Pharmaceutical Chemistry from the University of Toronto, Post-Graduate Certificate in Pharmaceutical Regulatory Affairs and Quality Operations (RAQ) from Seneca College and Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS). When she’s not learning something new, Delsie loves spending time with family, going on road trips or long walks, and swimming.

     


    Jennifer Porter

    Since joining the FPR team in 2011, Jennifer has become our VP/GM managing all staff and projects in the corporate portfolio. She is responsible for finance, accounting and all aspects of IT.

    Jennifer obtained an MBA from University of Redlands, located in Southern California and a B.A. in Psychology from Hawaii Pacific University. When not supporting the needs for her clients, Jennifer enjoys golfing, live music, and traveling.