Rapid medical advances and new technologies make medical device manufacturing an exciting industry.
But cutting-edge companies also face considerable challenges, as each new product must meet rigorous regulatory standards. As a medical device manufacturer, you want to ensure that your goods are effective and safe for consumer use. But you also want to minimize the costs and constraints of regulatory compliance with regulations like ISO 13485 and the FDA’s QSR.
CompliantPro ensures compliance with regulations like ISO 13485, ISO 14971 and 21 FDA Parts 11 & 820. The medical device compliance software system allows you to increase efficiency for your quality processes, minimize the high costs of compliance, and quickly bring products to market.
With IBS CompliantProMD software for Medical Device Quality Management, you can:
- Create and maintain all of your quality system documentation including Device Master Records and Design History Files
- Perform corrective and preventative actions
- Record and resolve customer complaints
- Perform effective employee training
- Create, execute and track assessments
- Evaluate suppliers
- Manage nonconforming material
- Manage gage calibration and preventative maintenance
- Drive advanced product quality planning throughout your entire product life cycle
Before CompliantProMD Software: Companies struggled to maintain vast amounts of data necessary for product planning. When performing quality activities such as internal audits and corrective actions, poring through records to find needed documentation wasted valuable employee time.
After CompliantProMD Software: All documentation for policies, procedures, specifications, Device Master Records, Device History Records, and Design History Files are stored in a secure, password-protected medical device compliance software location. With easy search and retrieval, a few clicks are all it takes for users to access the file they want. Auditors appreciate electronic, accessible documentation.
Before CompliantProMD Software: Quality departments performed separate sets of processes for compliance with ISO 13485 and ISO 14971. By failing to incorporate risk management into quality processes throughout their product life cycle, they did not fully anticipate and prepare for all potential risks. Companies also increased costs by maintaining separate programs for similar activities.
After CompliantProMD Software: Companies integrate processes for both ISO 13485 and ISO 14971, and achieve reduced risk, lower costs, and the elimination of duplicated efforts. They establish centralized document control and communications for all compliance efforts, making it easier to implement and maintain an enterprise quality management system.