MedTech Intelligence has compiled a list of the most-read articles over the past few months.

5. Failure of Management with Executive Responsibility

Dr. D catches another rarely cited Form 483 observation: The failure of management with executive responsibility to actually review the quality management system they have been entrusted with managing.

4. Medtech Powerhouse: Abbott to Acquire St. Jude for $25 Billion

The union of the two companies creates a market opportunity of nearly $30 billion and a powerhouse in in cardiovascular and neuromodulation markets.

3. Cook Recalls More than 4 Million Catheters

According to FDA, Cook Medical found an increase in reports related to the polymer degradation and identified environmental conditions, as potential contributing factors.

2. Boston Scientific Restructures, Expects to Reduce Headcount

The global restructuring program is expected to reduce the company’s gross annual pre-tax operating expenses by about $115–$150 million by the end of 2020.

1. ISO 13485:2016 – What Are the Changes About?

How to prepare for a successful transition.