Face your audit with confidence.
Medical device companies of Class I, Class II and Class III can establish automated revision control of their bills of material (BOMs), device master records (DMRs) and design history files (DHFs) on a validated system with Arena. Arena enables medical device companies to streamline quality and compliance documentation and reduce product errors.
Our collection of resources provides tips and tactics to help you address FDA regulations 21 CFR Part 11 (Electronic Signatures) and 820 (Good Manufacturing Practices) and ISO 13485 requirements, manage compliance documentation and face your audit with confidence.
Your resources for Medical Device companies:
This whitepaper gives insight into how automated, electronic solutions can help medical device companies better manage their bill of materials (BOMs), device master records (DMRs), design history files (DHFs) and change orders.
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Best practices and guidelines to use when moving from a paper change order process to an electronic change management system are discussed in this whitepaper.
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Align Technology, a class II medical device company, cut compliance costs by more than $250,000 annually and reduced their change implementation time from 22 days to 3-5 days.
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Novare Surgical Systems, medical device manufacturer, expects to reduce ECO cycle times by 70 percent and speed time to market by 10 percent.
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