With Artificial Intelligence penetrating the pharma world at a rapid pace, three regulators have joined forces with the aim of fostering Good Machine Learning Practice (GMLP).

The US FDA, UK’s Medicines and Healthcare products Regulatory Agency, and Health Canada | Santé Canada have come together to release a set of 10-founding guidelines which they believe will support the development and maturation of the tech as it becomes ever more prevalent across the industry.

The “Good Machine Learning Practice for Medical Device Development: Guiding Principles” aims to help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML) and are a great first step in setting standards for this key area.

These initial 10 guiding principles identify areas where the International Medical Device Regulators Forum (IMDRF), International standards organizations and other collaborative bodies could work to advance GMLP. Areas of collaboration include research, creating educational tools and resources, international harmonization, and consensus standards, which may help inform regulatory policies and regulatory guidelines in the years to come.

As the AI/ML medical device field evolves, so too must GMLP best practice and consensus standards. As avid believers that the advancements brought from such technologies should be embraced, QUINTA-ANALYTICA, who have previously featured how progress in this area is being felt in their labs and across their business, celebrate this solid step forward and hope it attracts further collaboration from more industry bodies.

Find out more about the guidelines on fda.gov, and read more about Quinta and how they utilize the latest and greatest technology right here at Quinta.cz

Additional News

  • 18 March 2024

    News from our newly opened clinic in Ostrava

    Our new Clinic in Ostrava (CZ) is gaining momentum step by step; therefore, we have some interesting news for you from the center of the action.

  • 19 December 2023

    Happy new year 2024

    As we bid farewell to 2023, it's time to express our deepest gratitude for the collaboration.

  • 4 December 2023

    Our new clinical unit in Ostrava comes to life

    It's a great pleasure to announce that after two years of hard work, the brand-new clinical unit in Ostrava with 36-beds capacity has been opened.