Rania deLeon
Learn how PPMDM modernized its QMS with Fusion Manage, saving $300K+ through automation, audit efficiency, and cloud-based document control.
In the highly regulated world of medical device manufacturing, having a reliable and efficient Quality Management System (QMS) isn’t just a regulatory requirement. It’s a strategic imperative. At Pressure Products Medical Device Manufacturing (PPMDM), our journey toward compliance, efficiency, and innovation led us to adopt Autodesk Fusion Manage product lifecycle management (PLM) as the backbone of our quality system. Through my company, Mina Methods LLC, I’ve had a front-row seat to the transformation. This is our story, and why Fusion Manage was the right choice.
The challenge: Complex requirements, limited resources
PPMDM manufactures over 60,000 cardiac surgical devices annually, exporting to over 40 countries. Despite operating in a global and highly scrutinized market, our team is lean, fewer than 15 people, including assembly line staff. For a business of our size, managing a compliant and efficient QMS meant finding a system that was not only powerful but also flexible, configurable, and scalable. Traditional “out-of-the-box” QMS platforms simply didn’t meet our needs.
Autodesk Fusion Manage: Connect People, Processes, and Data
Streamline workflows, enhance collaboration, and gain real-time visibility with PLM.
Why Fusion Manage?
We selected Autodesk Fusion Manage for three core reasons: configurability, flexibility, and automation. These features allow us to build custom workspaces, workflows, and checks into every part of our quality operations. With Fusion Manage, we can design processes that reflect our actual business practices instead of conforming to the limitations of rigid systems.
For instance, if we need a tooling management system or a preventive action plan that meets our unique processes, we can script and build it directly in Fusion. We’re not at the mercy of external vendors or forced to use workaround procedures that don’t truly solve the problem.
The real value of QMS: Training, audits, and document control
1. Smarter training, lower costs
Training is foundational to a quality system. Every employee must be competent in the procedures they perform. Before Fusion Manage, tracking training was manual and labor-intensive. With Fusion Manage, the system automatically assigns, monitors, and enforces training actions. Employees can’t perform tasks unless they’ve completed the required training. This is built directly into the system logic.
This automation has saved us significant resources. Consider this: each training event is roughly 12 hours and a training manager’s hourly rate is about $54. By automating and streamlining the training process across 285 training events, you can save $184,680 in potential costs.
2. Audit efficiency without the stress
Audits used to be high-stress, multi-person events involving front rooms, back rooms, document runners, and tons of paper. Fusion Manage has changed all that. Today, a three-person team runs our audits with two monitors—one for document retrieval and one for display. Because we centralize, version-control, and keep our documentation audit-ready, we enter audits with confidence.
Process automation ensures that all SOPs are followed, approvals are in place, and records are complete. We’re not scrambling during an audit. We’re showing off.
By streamlining our audit preparation and execution, we’ve reduced internal resource demands by an estimated 50%, allowing us to reallocate over 120 hours annually toward value-added quality initiatives instead of administrative audit prep.
3. Cloud-based document control
Fusion Manage’s cloud-based document control system allows us to review and approve documents from anywhere in the world. I’ve personally reviewed and signed off on documents while traveling internationally. The system maintains version control, document history, change tracking, and regulatory retention, all accessible via custom workflows and user permissions.
The system links documents to their associated change orders, and employees can easily differentiate between effective and superseded versions. This not only ensures compliance but also simplifies audits and training.
Remote access and streamlined document workflows have reduced document turnaround times by over 60%, accelerating project timelines and improving cross-functional collaboration without adding headcount.
The gatekeeper: Device release checklist
One of the most powerful tools we’ve built in Fusion Manage is the Device Release Checklist, our last quality gate before a product hits the market. This checklist ensures that all aspects of quality, safety, regulatory compliance, and contractual obligations are met. The system verifies that training, sterility, labeling, risk management, validations, and other criteria are satisfied. Once the checklist is approved, a Certificate of Conformance is auto-generated for final QA review and signature.
Building a better QMS
We didn’t just implement Fusion Manage. We customized it to work the way our business works. Here’s how we built a fully integrated quality ecosystem:
Training integration
Only trained employees can only perform procedures on them. Fusion Manage manages assignments, prevents unauthorized access, and tracks completion dates. The system centralizes training records, eliminating scattered spreadsheets and keeping everything audit-ready.
Device master record and lot records
Each product has a Device Master Record (DMR) that contains design, inspection, and manufacturing details. The system automatically links lot records to DMRs and includes all necessary documentation, validation steps, supplier statuses, tool checks, and even material expiration dates. The system enforces workflow rules so teams follow only validated procedures with compliant tools and materials.
Supplier and tooling management
Suppliers can’t be used unless they’re approved. Fusion Manage tracks certifications, insurance, NDAs, and quality agreements, ensuring suppliers remain compliant. The same is true for tooling. Only calibrated and validated tools can be used in production. This level of automation reduces risk and eliminates the need for full-time staff just to manage these elements.
Quality events and CAPA
Fusion Manage makes it easy to document, track, and resolve quality events. Corrective and preventive actions (CAPAs), supplier quality action reports (SCARs), and non-conformance reports (NCRs) are linked and traceable. Change orders can be initiated from any quality event, and root causes are easily documented. This creates a robust closed-loop quality system that actually drives improvement.
Workflow approvals and action items
Fusion Manage’s workflow capabilities are the engine behind our compliance culture. The system tracks action items to completion, validates approvals through role‑based access, and prevents closure until all tasks are complete. We no longer worry about missed signatures or undocumented activities. Fusion Manage ensures accountability and traceability.
Design controls for better products
Fusion Manage supports traceability across user needs, product specifications, design requirements, risk assessments, verification/validation plans, and post-market surveillance. With this approach, teams build every product to spec, test it thoroughly, and meet regulatory requirements. Better design control leads to fewer complaints and fewer recalls.
Final thoughts
Autodesk Fusion Manage has transformed our quality system from a compliance burden into a competitive advantage. Its configurability has allowed us to build a QMS that fits our processes, not the other way around. Its automation has freed us from manual errors, saved us money, and given us peace of mind. And its flexibility has empowered a small team to operate at a level that meets, and often exceeds, the standards of multinational corporations.
In the first three years of our QMS journey with Fusion Manage, PPMDM realized over $300,000 in measurable operational savings from training, audits, and document control. And the return has only grown in the years since the rollout, as the platform continues to scale with our operations.
The return on investment, both in efficiency and peace of mind, has been invaluable to us at PPMDM.
About Rania deLeon
Rania deLeon is a seasoned Quality Assurance and Regulatory Affairs Manager with over ten years of experience in the medical device industry. As CEO of Mina Methods LLC, she excels in regulatory compliance, quality management systems, and process improvement, with expertise in FDA regulations and ISO standards. Rania is pursuing a master’s in law from Penn Carey Law School and holds a Bachelor of Science in Biomedical Engineering from Drexel University. She has authored numerous regulatory submissions, led quality assurance programs, and collaborated with regulatory bodies. She has extensive expertise developing quality management systems using Autodesk Fusion Manage. Rania’s commitment to excellence in quality and regulatory affairs, coupled with her leadership experience, makes her a notable figure in the medical device sector.