By Laurel Hacche and Debra Cortner, SQA Associates Health Canada Regulations/Guidances Regulation of Vaping Products in Canada, December 2019 On 19 December 2019, Health Canada announced the final “Vaping Products Labelling… read more →
By Laurel Hacche, SQA Associate SQA Regulatory Surveillance Summary for Q3-Q4, 2019 United States Food and Drug Administration (US FDA) Guidances (Devices and Drugs) Device Guidance: Intravascular Catheters, Wires, and… read more →
By Boudewijn Jong, SQA Associate, Netherlands Synopsis On 20 May 2020, the new European Union Medical Device Regulation (EU MDR) will go into effect. All Medical Devices manufactured and/or sold… read more →
Wins & Challenges It was a crazy summer for the McKay family. After dropping our son off at LAX to attend college overseas, my wife Carrie and I headed to… read more →
SQA Regulatory Surveillance Summary for Q2, 2019 International Council for Harmonization (ICH) Guidance ICH Harmonized Guideline, Optimization of Safety Data Collection, E19, Draft April 2019 This Guideline is intended to… read more →
Wins & Challenges Summer has started, along with some amazing scenery in California, since we’ve had periodic rain with a generous amount of sun. SQA has been evolving the past… read more →
Wins & Challenges Summer this year is an especially interesting time for my family. Crazy times approach, as I will be taking my daughter off to college in the next… read more →
European Federation for Cosmetic Ingredients (EFfCI) No updates noted as of 09 March 2017 European Medicines Agency (EMA) Guideline on the Chemistry of Active Substances, 15 November 2016, EMA/454576/2016 The… read more →
Wins & Challenges When it rains, it pours! This spring, massive rains have consistently fallen on our beautiful state of California, finally ending a years-long drought. Water rationing had been… read more →
You may be in the process of upgrading your Quality Management System to the new ISO 9001:2015 requirements, but don’t forget that there are new changes to the ISO 13485… read more →