How to Reduce Regulatory Delays by Formalizing Design Control Processes

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
• Streamline compliance and audits