…of global healthcare strategy at UPS MedTech Intelligence: What challenges do you see medical device companies facing when they seek to enter new global markets? Josh Cannon: Medical device companies…
…of global healthcare strategy at UPS MedTech Intelligence: What challenges do you see medical device companies facing when they seek to enter new global markets? Josh Cannon: Medical device companies…
In a move to expand its neuromodulation portfolio, Boston Scientific has acquired Cosman Medical for an undisclosed amount. The privately held company manufactures radiofrequency ablation systems for neurosurgery and pain…
In a move to expand its neuromodulation portfolio, Boston Scientific has acquired Cosman Medical for an undisclosed amount. The privately held company manufactures radiofrequency ablation systems for neurosurgery and pain…
…In response to this competition, some Western cardiovascular companies are coming out with new “valve-oriented” devices. Microport and Lepu Medical, $2 billion-dollar Chinese medtech companies, are leading developers of CVD…
…In response to this competition, some Western cardiovascular companies are coming out with new “valve-oriented” devices. Microport and Lepu Medical, $2 billion-dollar Chinese medtech companies, are leading developers of CVD…
…Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (June 2016). Inspections, Compliance, Enforcement, and Criminal Investigations….
…Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (June 2016). Inspections, Compliance, Enforcement, and Criminal Investigations….
FDA just released a draft guidance to assist with compliance with the Unique Device Identifier (UDI) rule. The UDI rule requires that most medical device labels and packages have a…
FDA just released a draft guidance to assist with compliance with the Unique Device Identifier (UDI) rule. The UDI rule requires that most medical device labels and packages have a…
…companies require suppliers to deliver more lightweight yet powerful components, modules and chips, or dedicated energy and data storage systems. As the number of people developing chronic diseases continues to…
…companies require suppliers to deliver more lightweight yet powerful components, modules and chips, or dedicated energy and data storage systems. As the number of people developing chronic diseases continues to…
…nature of the compliance transgressions, while employing several consultants (consultants x hourly rates = many, many, dollars). In fact, by the time this entire process comes to an end, there…
…nature of the compliance transgressions, while employing several consultants (consultants x hourly rates = many, many, dollars). In fact, by the time this entire process comes to an end, there…
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…
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…
…wrong regulatory consulting company. There is a severe shortage of efficient and competent Japanese RA executives. For example, a few weeks ago a U.S. medtech company contacted me about its…
…wrong regulatory consulting company. There is a severe shortage of efficient and competent Japanese RA executives. For example, a few weeks ago a U.S. medtech company contacted me about its…
…response. If the FDA later denies the exemption request, that labeler will have to act fast to comply with UDI compliance deadlines—and UDI compliance is not a process that companies…
…response. If the FDA later denies the exemption request, that labeler will have to act fast to comply with UDI compliance deadlines—and UDI compliance is not a process that companies…
