Will connected health live on, in a post-pandemic Asia-Pacific region?
We take regulation and compliance very seriously, and helping us meet our Australian and international milestones is our amazing Regulatory Compliance Manager, Marzia Signoroni.
Marzia manages Visionflex’s regulation and compliance program which includes annual quality management system audits and keeping abreast of new iterations of global licensing requirements. Marzia also oversees Visionflex’s own ongoing internal audit and review program.
Marzia’s latest achievement has been guiding the Visionflex team through the Medical Device Single Audit Program (MDSAP).
“Receiving the MDSAP has been a big achievement,” said Marzia who has specialised in quality assurance for more than 10 years.
“The process took time and required great attention to detail. There are so many regulations in different parts of the world and different jurisdictions, so we need to make sure that we are registered and always in accordance with regulation changes.
“Working in compliance with regulations and standards can reduce errors, making sure that every step of the process within our organisation is under control and it’s done in a way that fulfils regulatory requirements and provides a good quality product.
“It is especially important as we manufacture medical devices which are higher risk products.”
The Visionflex team designs and manufactures telehealth hardware and medical devices that are classified as Class I medical devices by Australia’s Therapeutic Goods Administration (TGA).
The medical device industry is heavily regulated. Most countries will have their own unique licencing and registration requirements and it is important that Visionflex’s global customers feel confident every time they use our quality products.
Visionflex products are IEC 60601 compliant, making them suitable for clinical medical assessments. Visionflex is also certified ISO 13485:2016 for the manufacture of non-sterile image capture and data storage systems for medical devices.
Our products are available in Australia, the Middle East, Asia, Europe, India, Canada, and the USA.
Marzia’s career began at age 19 in her native Italy. She was studying for a business degree at the University of Bergamo and working in the highly regulated automotive industry. From day one, Marzia says she knew compliance was a great fit for her personality and her love of logic! In fact, one of Marzia’s favourite past times is watching ‘How it Works’ and ‘How it’s Made’ videos on YouTube.
“I enjoy the logical nature of this role and understanding how it all works together,” said Marzia who hails from the city of Brescia in northern Italy. “The most exciting thing for me is to understand how it all works together in accordance with regulations.
“Regulations are rapidly changing and are different in each country, and I enjoy the fact that I am constantly learning and understanding how to progress in order to obtain approvals or access a new market for Visionflex.
“My job is never exactly the same: I love to be able to adapt our QMS and documentation in accordance.”
Marzia relocated to Australia in 2012. Her first impression of her new home was that compared to Europe, Australian society is relaxed and easy going.
In 2019, Marzia joined the Visionflex team, which is based on Sydney’s Northern Beaches. She enjoys the challenges that her role entails and working with a tightknit team of colleagues.
“And I love the Visionflex products,” she said. “I think they can make a huge impact on peoples’ lives, so this makes my job easier. I feel trusted and supported from management and the team as well, which makes my days at work pleasant, and often fun; in fact, we have a great team!”
In her spare time, Marzia is studying for an MBA and whenever she can grab a moment, she enjoys running, pilates and playing tennis with her partner. Marzia’s next mission is launching the inaugural Visionflex Tennis Cup!
“Sport is essential to me,” said Marzia.
Marzia’s other love is explaining ‘how things work’ and ‘how things are made’ to her two young daughters.
“Why does the sun shine? How are cakes made? You know, all those questions that children ask!”
Visionflex is a leader in telehealth technology. The company was formed in 2014 by two Australian engineers with the mission of making world-class healthcare available to everyone, everywhere.
From Antarctica to the Middle East, Europe, Asia, India, Canada, and the USA, Visionflex is helping to improve health outcomes around the globe.
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