The medical device industry faces heavy regulations. With lives at stake, patient safety is of the highest importance. Failure to adhere to FDA, EU, and other standards and regulations leads to embarrassing and costly product recalls. The case for quality and compliance is critical. Listen to global medical device manufacturers discuss their approach to the Case for Quality.
Claus-Peter Gärtner, Roche Diabetes Care, and Michelle Boucher, Tech-Clarity, discuss how a product centric approach and PLM help Roche Diabetes Care balance quality, compliance and innovation.
Listen to Tina Kunshier, Boston Scientific and Michelle Boucher, VP of Research for Tech-Clarity, to understand how Boston Scientific balances quality, innovation, compliance, and profitability.
Lisbeth Sivertsen, expert for product quality strategy at Novo Nordisk discusses quality rigid global regulations including FDA and other global standards.
Lluís Gomez discusses how manufacturers should respond to rigid FDA or EU regulations and authorities.
The Case for Quality allows firms to determine how products are performing in real-world scenarios during all three lifecycle stages — premarket, production, and post-production.
Hear about the top medical device industry business disruptors.
Discover the best selection criteria for choosing the right software to support quality initiatives.