Visual Work Instructions for Medical Device Manufacturing That Support FDA Compliance
Medical device manufacturers operate under a straightforward mandate: produce a safe and effective product, every time. Sequence gives Medical Device Manufacturing teams the tools to create, control, and deploy visual work instructions that keep every operator on the latest approved standard — with full traceability to every part, lot, and revision.
Industry Challenges in Medical Device Manufacturing
The compliance challenge in Medical Device assembly
Whether you're building reusable surgical instruments or high-risk Class III implants, the assembly process must be perfect, repeatable, and verified. Paper instructions and generic PDFs fail to prevent the 'tribal knowledge' shortcuts that lead to non-conformances during audits.
21 CFR Part 11 electronic signatures
FDA regulations require strict controls over electronic records and signatures. Manufacturing teams need a system that ensures only authorized, trained individuals can sign off on critical process steps. Maintaining this level of control in a fast-paced production environment without specialized software often leads to gaps in the audit trail.
Device History Record support
Manually compiling DHRs is a significant administrative burden that delays product release. Without an integrated system, quality teams spend hours chasing signatures and verifying that the correct revisions were used for specific lot numbers.
Controlled instruction deployment for regulated production
Deploying new instructions across multiple lines or shifts requires synchronized control. If an operator accidentally uses an obsolete revision, the entire lot may need to be quarantined or scrapped, impacting time-to-market and profitability.
Key Sequence capabilities for Medical Device Manufacturing
Work Instruction Revision Control
Work instruction revision control and electronic approval workflows.
Part and Batch Traceability
Detailed traceability of every part, lot, and serial number produced.
FDA 21 CFR Part 11 Compliance
FDA 21 CFR Part 11 electronic signature and audit log support.
In-Process Quality Checks
Mandatory in-process quality checks and measurement capture.
DHR Generation
Automated compilation of electronic Device History Records (eDHR).
System Interconnectivity
Direct connectivity with PLM, ERP, and QMS systems to maintain data integrity.
Ready to optimize for Medical Device Manufacturing?
Supporting FDA inspection readiness
Sequence is designed to be a core part of your quality system, ensuring that the work instructions used on the shop floor are exactly those reviewed and approved by quality engineering. By managing the full lifecycle of instructions within a validated state, Sequence provides the documented evidence needed during regulatory audits.
Electronic signatures, revision history, and controlled deployment allow you to demonstrate high-level process control to inspectors. With Sequence, you can confidently show that only the latest, approved standards are in use, significantly reducing the risk of compliance-related observations.