Medical device manufacturers operate in one of the world’s most highly regulated industries, which makes the needs for a special manufacturing ERP system even more important. When success can hinge on time-to-market, traceability, quality management and compliance with the latest regulatory requirements, a medical device ERP can add loads of value. Whether a company is a venture capital medical device start-up, or a growth-oriented medical device company, each must follow closely controlled processes to develop and manufacture products so they meet the strictest quality standards. Let’s explore the industry obligations and the top factors you should consider in a medical device erp.
To fully manage quality and track all data related to products across the entire supply chain, the ERP needs of medical device manufacturers must be met with systems that monitor production, purchasing, documentation, and traceability of products, and do so while cost-effectively managing compliance requirements.
The U.S. Food and Drug Administration (FDA) 21 CFR 820 QMS requirements are in place to ensure product safety and efficacy of medical devices. Good manufacturing practices require medical device manufacturers to apply relevant sections of FDA Part 820 to their operations. This makes an appropriate ERP a critical piece of an overall quality management system for medical devices—one that must be validated for regulatory agencies.
Medical device ERP software should help companies meet all FDA requirements for both software and operations. Manufacturers should look for comprehensive compliance monitoring, quality management (QM) and supply chain management functionalities.
To ensure your intended Medical device ERP checks all the boxes, you first need to identify what those boxes are. Here are the top 10 things to look for when evaluating a new ERP system for your organization, such as QAD for life sciences. It should:
Strategic Information Group helps medical device companies leverage QAD ERP for life sciences, and also offers a full range of medical device solutions including ERP, CRM, and QMS. We help venture capital medical device startups commercialize and established companies reach their exit strategies, such as IPO or company sale.
The Strategic team serves medical device manufacturers in the San Francisco Bay Area, Southern California, Boston, and other regions across North America. We help each client meet the critical needs of Life Sciences manufacturers:
Get our free ERP RFP template, designed specifically for the needs of Life Sciences companies by contacting a Strategic representative.