Inhaled cannabinoid developer Senzer said that it believes the company is the first to receive ISO 13485:2016 certification for design and development of a pharmaceutical-grade cannabinoid delivery device.
Senzer’s Systemic inhaled Delivery Device (SiDD) platform recently won two design awards, a 2018 Good Design Award and an iF Design Award. The company is developing several cannabinoid products delivered via the SiDD device, including dronabinol and cannabidiol inhalers.
Senzer Quality Director Lester Gleeson commented, “Achieving this ISO certification is an essential prerequisite for us on our road to market approval, and the team at Senzer are of course very excited that our quality system has been independently validated. We will now be working towards the next regulatory milestone, which will be to have our devices CE marked.”
Senzer CEO Alex Hearn said, “Our approach enables users to enjoy swift, certain and non-invasive delivery of prescribed actives, and we believe this will be of great benefit to our initial targeted patient groups. Our breakthrough device has numerous applications for delivering cannabinoid formulations, and not just in the pharmaceutical sector.”
Read the Senzer press release.
