Choosing the Right Medical Device Manufacturing Software: What to Look For in Production & Shop Floor Tools
Medical device manufacturing demands precision, traceability, and strict compliance - from cleanroom builds to FDA audits. Most ERP systems on the market don’t fully address these realities. Whether you’re building Class I components or managing serialized implants, your production software needs to match the regulatory expectations. Here’s what to look for in ERP tools built specifically for medical device manufacturing.
Why Medical Device Manufacturing Is Different
Manufacturers in the medical device and life sciences space operate under some of the most stringent regulations in the industry. Standards such as FDA 21 CFR Part 820 and ISO 13485 require rigorous process controls, traceability, and documentation throughout production. These regulations are not suggestions - they are enforced mandates that directly impact how your production floor operates.
From maintaining cleanroom documentation to tracking device history records (DHRs), every step of production must be controlled and logged. Serialized components, unique device identifiers (UDIs), and software validation further complicate operations. The ERP system you choose must be able to support this level of control and visibility without burdening your production staff.
Essential Production Tools in Medical Device ERP Software
To meet these requirements, production tools within your ERP system must be purpose-built for compliance and efficiency. Here are key capabilities to look for:
- Lot and serial tracking – Full traceability from raw material to finished product, with serialized data linked to device history records.
- Cleanroom-compatible routing and equipment tracking – Define cleanroom steps and log equipment usage, ensuring proper environmental control.
- Real-time WIP dashboards – View current status of every work order, with labor, materials, and equipment logged in real time.
- Integrated work instructions and sign-offs – Deliver digital instructions to operators and capture user initials, measurements, and validations at each step.
Without these tools, your team risks manual tracking errors and compliance gaps that can delay audits or trigger costly rework.
Quality and Compliance Built Into Production Workflows
Compliance isn’t a separate module - it needs to be part of every production step. Your ERP should embed quality controls directly into shop floor processes.
- In-process inspections - Capture inspections and pass/fail data within the work order, triggering holds or rework automatically.
- Nonconformance and CAPA tracking - Link inspection failures to NCRs and corrective actions, with full audit trails.
- Automated document control – Maintain version control on SOPs, drawings, and certs, ensuring the right documentation is delivered to the floor every time.
These tools reduce paperwork, enforce process consistency, and ensure you’re always ready for an audit.
How Cetec ERP Supports Medical Device Manufacturing
Cetec ERP is designed with regulated industries in mind, offering end-to-end production tools that meet the unique demands of medical device manufacturing.
- Integrated traceability - Track every lot and serial number from receipt through build, with full linkage to BOMs and final shipments.
- Controlled document management - Store and distribute SOPs, certificates, and drawings within a revision-controlled system tied to work orders.
- Audit-ready digital records - Automatically generate device history records, nonconformance logs, and sign-off histories for FDA or ISO inspections.
- Shop floor efficiency - Use barcoding, real-time labor tracking, and equipment logs to manage operations without compromising compliance.
With Cetec ERP, you don’t have to choose between compliance and productivity - you get both, in one integrated system.
Key Takeaways:
- Medical device ERP must support traceability, quality, and compliance.
- Shop floor tools need to be tightly integrated with documentation.
- Cetec ERP provides built-in workflows designed for regulated manufacturing.
The right software ensures your shop floor is not only productive but always audit-ready. Cetec ERP gives medical device manufacturers the tools to maintain full traceability, enforce quality, and meet regulatory standards without slowing down production.
Looking for software that fits the needs of medical device production? Learn how Cetec ERP helps your team meet compliance requirements while improving shop floor efficiency - book a live demo today.