Professor Simon Fraser discussing human centred design to a table at the HealthTech Week conference

Regulatory and Design Requirements

The design and design process for medical technologies has many factors to consider.

Medical technology is a highly regulated industry to ensure the safety and efficacy of new products. Compliance with these regulations is crucial to protect patients and gain market approval. For early-stage MedTech developers, understanding and integrating regulatory requirements and quality management systems (QMS) from the outset is essential.

Adopting a human-centred design approach ensures that medical technologies meet the diverse needs of all users, including patients, healthcare providers, and caregivers. This approach focuses on creating products that are not only safe and effective but also intuitive and user-friendly.

Workshops

A laptop screen displaying a head band type medical device

Demystifying Quality and Regulatory

An introductory workshop to quality management and regulatory requirements for medical devices.

See the events page for the next workshop.

A table discussion with a group of attendees

Medical Software Regulatory Requirements

An introductory workshop to the topic of development, quality assurance and approval of medical software.

See the events page for the next workshop.

Resources

Greenlight Guru

An online QMS designed for medical devices. Researchers can try this platform and access a number of templates for free by contacting us below.

Office Hours

If you would like to speak to one of our experts in quality management and regulatory requirements, please contact us.

QMS Series - HealthTech Activator

The HealthTech Activator have developed a series of resources on quality management systems and understanding ISO 13485.

Mātauranga Māori

To effectively partner and engage with Māori communities, first attend the Whaia te Tika workshop series, followed by the Kaupapa Māori research ideation one-on-one office hours assistance to refine your approach.

Pacific Engagement

To effectively partner and engage with Pacific communities, attend the Vaka Moana workshop and speak to the Pacific Engagement module leads about your project.

Digital Health

Regulatory and Design Requirements

Workshops

Resources

Mātauranga Māori

To effectively partner and engage with Māori communities, first attend the Whaia te Tika workshop series, followed by the Kaupapa Māori research ideation one-on-one office hours assistance to refine your approach.

Pacific Engagement

To effectively partner and engage with Pacific communities, attend the Vaka Moana workshop and speak to the Pacific Engagement module leads about your project.

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