Medical devices are optical, medical and mechatronic systems all rolled into one. Advanced medical devices are subject to complex requirements and stringent FDA and ISO regulations as gatekeepers for approval on national and international markets.
All medical devices are subject to the rigorous regulations of the US organization FDA up to and beyond their launch on the market.
Medical technology is a highly dynamic and innovative field. However, investment in innovative technologies is not the only cost factor involved; market approval for medical devices in accordance with FDA regulations is also a major driver of product and process costs. An end-to-end PLM solution ensures transparency and effectively manages costs and time to market.
FDA – the prime authority
The FDA’s regulatory measures are based on quality management preconditions, requiring strict process management and traceability of documentation. FDA QSR – Quality Systems Regulations – are set forth in 21 CFR Part 820.xxx (Code of Federal Regulation) Part 820.
The most important elements are:
- DMR – Device Master Record, containing all instructions and specifications for the device and its production, quality assurance, packaging and labeling, installation, maintenance, and service.
- DHF – Device History File, providing evidence that every production batch and every device was produced according to specification and containing the date of manufacture as well as details of production volume, final inspection, and component and device serialization.
- Controlled documents cover many document categories, spanning specifications, models, drawings, layouts, industrial engineering documentation, work instructions, manufacturing documents, test records etc.
The provisions of Part 11 impose clear requirements for unique identification and authorization of PLM users, including digital signatures. Releases, approvals, changes, and amendments must be executed within closed-loop environments with full traceability and accompanied by full documentation.
We provide Oracle’s Agile PLM (A9) as an industry-specific PLM solution that is virtually perfect for all requirements of the FDA-regulated Medical Device industry.
PLM synchronizes company operations
An FDA QSR-compliant PLM system is based on a dataset of relational database objects which are managed dynamically, e.g.
- The electronic DMR – Device Master Record (requirements, master data, BOMs, documentation),
- The electronic DHF – Device History File (completed engineering phases and milestones, data concerning creation, review, verification and validation, and changes),
- The numerous GRC – Governance Risk Compliance – documents, and the
- R/A – Regulatory Assurance – documents.
FDA and ISO conformity can be integrated into the PLM, slashing organizational costs and efforts. System-controlled workflows can always be consistently planned and executed and seamlessly tracked.
Lower product costs and reduced management workload thanks to
- PLM-controlled documents,
- Lean approval and change processes,
- Trackable DMRs and DHFs, stored centrally and securely in the databsae and file vault,
- Rapid access for users and auditors,
- Consistent data and files thanks to PLM‘s validity control.
Improved product quality in accordance with FDA QSR-21 regulations and ISO 13485 conformity, delivered by
- CAPA and closed-loop functions,
- Lower fault and failure rates over the short and medium term,
- Documented and role-based processes and authorizations (Part 11).
FDA conformity of the PLM system provides support with central data repository and auditable document archive.
Every dataset exists only once within the system. The history table documents all database processes for a dataset in a non-rewritable, non-erasable format. The FDA dataset comprises
- DHF planning with project plan, resources, conditions, risk analysis
- Design data with specifications, master data, documentation, verifications, validations, testing and inspection results
- Process data with changes in engineering and manufacturing, history, change documentation, nonconformities
- Procurement data with manufacturer, incoming goods inspection, price and delivery capacity
- Production order data from PLM-ERP and, where required PLM-MES synchronization,
- Q management with CAPA, compliance, audit management, CRM.