Health Research BC: Medical Device Regulations

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Events

Health Research BC: Medical Device Regulations

When:
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Helen Simons, StarFish Medical Director of QA/RA, presented a comprehensive webinar titled “Medical Device Regulations” on October 22, 2024. This informative session was part of the ASK US webinar series organized by Health Research BC, aiming to provide clarity on the complex regulatory landscape for investigational medical devices in the US (FDA), EU (MDR), and Canada (Health Canada).

The webinar emphasized the importance of understanding regulatory requirements to ensure that medical devices are safe, effective, and compliant before their introduction into healthcare settings. Key learning objectives of the session included:

  • Understanding Regulatory Information: Identifying the essential information required to comprehend the regulatory requirements for medical devices across different jurisdictions.
  • Identifying Regulatory Bodies: Recognizing the primary regulatory authorities in the US (FDA), EU (MDR), and Canada (Health Canada) responsible for medical device oversight.
  • Risk Classification: Listing and understanding the various risk classifications for medical devices in these markets, which is crucial for determining the appropriate regulatory pathways.

For those who missed the live session, the recorded webinar is available on Health Research BC’s website. This resource is invaluable for professionals navigating the regulatory complexities of medical device development and seeking to ensure compliance across multiple jurisdictions.

Presenter Bios:

Headshot of Helen Simons.

Helen Simons

Director of QA/RA
StarFish Medical

Helen Simons brings over 15 years of experience in the medical device field, encompassing product development, quality systems, and regulatory affairs. Originally trained as an engineer, she has worked globally on a diverse range of medical devices and currently leads StarFish Medical’s Quality Assurance and Regulatory Affairs team.