ASK US: Medical device regulations

A medical device needs to be thoroughly tested before it can used in health care settings. This includes ensuring the medical device is safe, effective, and compliant with regulatory standards. In this session, we will look at the introductory content and questions to consider to help understand the regulatory requirements for an investigational medical device. We will cover three most common target markets: US (FDA), EU (MDR), and Canada (Health Canada).

Our keynote speaker for this episode is Helen Simons, director of quality assurance & regulatory assurance, Starfish Medical. Helen brings a wealth of knowledge about medical device regulations, with over 15 years of experience in the medical device field.

Join us for this exciting and timely topic in clinical trials to kick off season five of our ASK US webinar series.

Learning objectives 

The learner will be able to: 

• recall the key pieces of information needed to understand the regulatory requirements for a medical device 

• name the regulatory bodies for the US, EU and Canadian markets 

• list the different risk classifications for devices in the US, EU and Canadian markets 

Presenter

With over 15 years of experience in the medical device field, Helen brings a wealth of knowledge about product development, quality systems and medical device regulations. Originally trained as an engineer, she then transitioned through project management roles and found her true calling in the field of quality and regulatory. Helen has worked with clients around the globe to develop a wide range of medical devices, from minimally invasive surgical tools to novel drug delivery systems to point of care rapid diagnostic systems. She now leads StarFish Medical’s QARA team to help support clients and internal teams to develop successful and compliant products.