Every day, companies just like yours face medical device compliance realities and responsibilities associated with developing, producing, and distributing products that improve quality of life. To be successful, they continually need to produce innovative products that are clinically and economically relevant while facing strict regulatory requirements, increasing competition and demanding time-to-market and cost pressures.
However, many companies operate in silos. Different groups including Regulatory Affairs/Quality Assurance (RA/QA), project and product managers conduct product development and regulatory compliance functions using different information systems and long-established, disjointed manual and paper-based processes. The innovation process slows down when information is hard to retrieve and key decision makers lack a single view of all product- and process-related information. With a single collaborative system, medical device companies are able to:
- Connect quality, regulatory, and engineering, to deliver high-quality products, and to facilitate medical device regulatory compliance.
- Store all quality and compliance data centrally, track all product changes automatically, and provide necessary audit reports that link directly to a “living” electronic Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR).
- Provide full medical device traceability that is visible to all members of the quality, regulatory, and engineering staff, providing a Single Source of Truth for engineering, quality, and regulatory information.
- Simplify management of product engineering Bill of Materials (BOMs) and manufacturing BOM structures such as part versions and revisions, and alternate and spare parts.
- Accelerate medical device design, meet long-term business goals, and achieve operational excellence
- With all information residing in one comprehensive system, from packaging and unique device identifier (UDI) record to all quality and regulatory data including product complaints, NCRs, Warning Letters, 483s, audits, and CAPAs, medical device companies can connect the dots to address these challenges and more and stay ahead of the competition.
Download our expert whitepaper Beyond Compliance: Connecting the Dots Between Quality, Engineering and Regulatory to Increase Innovation & Improve Operational Efficiency to learn more.