Effective legal writing skills are essential for FDA submissions

professionals in the pharmaceutical and medical device companies clearly understand and effectively employ legal writing techniques to frame persuasive argument when negotiating with FDA

The Dynamic Learning Project: helping deliver on the promise of tech in the classroom

When it comes to schools, bridging the “digital divide” means more than providing access. While that gap isn’t yet closed, there’s another emerging equity imbalance that goes beyond computers or connectivity. This “second-level digital divide” is fueled by major differences in how effectively that technology is being used for teaching and learning. And it’s especially… via […]

The Ultimate Guide To Design Controls For Medical Device Startups

    What’s this guide about anyway? Back in 1998, I started my career as a medical device product development engineer. At that time the FDA Design Controls regulations were still fairly new — not only to me — but the industry in general. In those days, we all struggled to understand how and what […]

Quality Assurance Auditing for FDA-regulated industries

An effective audit constitutes the heart of an effective Quality System. The FDA and other regulatory agencies have emphasized this principle time and again. The purpose of an audit program is to ensure proper and thorough compliance with the guidelines set out by the regulatory agencies. A Quality Assurance audit should also ensure that the […]

Which universities are pushing the boundaries in life sciences?

If you had to name the branch of university research that has the most tangible impact on mankind’s day-to-day activities, it is likely that the life sciences would be near the top of the list: not many days go by without the announcement of a new drug or gene discovery that has the potential to change […]

Implementing ICH guidelines-compliant validation

Professionals in the field of statistical analysis need to possess clarity on understanding and interpreting statistical concepts used to investigate quantitative ICH Guidelines, such as: Analytical methods validation Procedures and acceptance criteria in calibration limits Process and Quality Control Process and quality controls ICH Q8 and Q9. The ICH tripartite-harmonized ICH Guideline on Text, which […]

An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls

Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem

Development of technical training in the life sciences

Developing Technical Training in the Life Sciences is a 2-day seminar that addresses the unique challenges of developing and managing training in Life Sciences companies. The Life Sciences pose unique challenges to training developers.

The ways of applying ISO 14971, IEC 62304 and IEC62366-1 to medical device software

Diligence, complete and proper examination and assessment of the gaps, and correction of the gaps right from the very start of product development are the core characteristics that need to go into implementing risk management of software used in medical devices. These are the reasons for it: Lack of proper and complete implementation and gaps […]