The exemption reduces the regulatory burden on the medical device industry—including the time and costs involved in preparing, submitting and responding to requests for additional information.
Medical device companies have upped their game in product security and regulatory compliance, but they might not be ready for a catastrophic event.
A Q&A on how device companies can respond to supply chain risks and regulations.
The company’s Bakken Research Centre in the Netherlands is centrally located for technology development and collaboration with physicians.
Regulations, cost pressures drive medical device companies to innovate.
Josh Cannon explains how technology can improve visibility throughout the supply chain.
Follow these contract manufacturing tips to boost margins and cut time to market.
Manufacturers should collaborate with a third-party logistics provider that has expertise in local in-country regulatory requirements and transportation security.
Product differentiation is important, but failing to nurture supply chain partnerships is a mistake that companies still make.
Stringent regulations, increased product protection challenges, economic pressures and contingency management have been identified as the most significant contributors to uncertainty in the healthcare supply chain.