Singapore’s Health Sciences Authority (HSA) has released for consultation draft guidelines on standalone medical mobile applications and qualification of clinical decision support software (CDSS). The ...

Kal Patel, MD, is CEO and Co-Founder of BrightInsight. He has over 20 years of experience in pharma, medtech and regulated digital health. Software as a Medical Device (SaMD) is changing how patients ...

The UK Medicines and Healthcare products Regulatory Agency has adopted a roadmap that details its plans for 2024, including future core regulations it plans to develop. On 9 December, MHRA published a ...

As AI and machine learning have become more important for the betterment of healthcare, the introduction of software as a medical device (SaMD) tools has shown promising results for doctors and ...

Navigating the SaMD regulatory pathways is one of the most complex yet important aspects of product development for medical technology startups. Startups in this field are required to meet local ...

Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices ...

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

The UK government has launched a consultation to gather views on the imminent updates of the current regulatory regime for medical devices, which include the application of technologies such as ...