How to Reduce Regulatory Delays by Formalizing Design Control Processes
April 11, 2017
Sponsored by Arena
The medical device industry stands at the crossroads between innovation and increased regulation. The lack of formal Design History Files (DHF) and Device Master Records (DMR) is one of the most important reasons for issuing non-conformance directives to medical device makers. Luckily, effective Product Lifecycle Management (PLM) solutions, such as Arena PLM, can help to facilitate proper management of quality documentation, and ease the pains of the regulatory approval process while accelerating time to market.
In this whitepaper, we outline how Arena PLM can help medical device companies achieve the following:
Improve design collaboration among global supply chain teams
Formalize design and document controls procedures and product record management
An innovative aircraft with electric drives combines the best of both worlds. The cross between drone and helicopter could mean significantly faster and more efficient air emergency...
Effective when other materials fail, ceramics are particularly suitable for applications requiring wear and chemical resistance, sliding characteristics or biocompatibility. Discover...
maxon drive systems are among the most flown drives in space research, and in space they power some of the most complex robotic systems that humans have ever built.
