Competing in a highly regulated industry
The medical device industry combines the complexity of highly engineered products with multiple, stringent regulatory requirements, in a market where failures can be catastrophic. The iBASEt Digital Operations Suite is designed for this kind of challenging environment, helping you maintain quality and stay competitive at the same time.
Benefits of Solumina for Medical device
iBASEt solutions help medical device manufacturers meet an array of regulatory requirements and standards including FDA’s 21 CFR Part 11 and CFR 820, ISO 13485, and ISO 9001. It also supports Six Sigma, CAPA, and other major initiatives.
Electronic Device History Records (eDHR)
We consolidate all compliance information into one centralized system, automatically updating the eDHR from design through production. This eliminates any chance of manual errors, making audits easier and less time-consuming.
Built-in Quality Management
Enterprise Quality Management is embedded within the iBASEt digital suite, which lets you hard-wire quality procedures directly into your production process. Utilize iBASEt’s Supplier Quality Management solution to manage the quality inspection of incoming supplier parts.
iBASEt provides strong control and visibility over lot and serial tracked parts for all materials, components, and subassemblies from “cradle to grave.” You can quickly see a product’s genealogy to determine if it has used a component or material that is out of compliance.
Work instructions can include illustrations, 3D-model animations, videos, slideshows, and built-in data collections and signature prompts. These and other standard features, such as alerts and inspection checklists, significantly reduce errors and improve quality.
Auditing and Reporting
Meet reporting requirements easily and generate audits when needed to ensure compliance with all internal and external standards.