Aras Medical Device Accelerator

The Aras Medical Device Accelerator is a preconfigured solution built on the Aras Innovator platform which delivers a regulatory-grade digital thread that embeds compliance directly into the product lifecycle. Designed for highly regulated global environments, it unifies design control, risk management, quality processes, and manufacturing definition within a single system to ensure continuous audit readiness and traceability from user needs through regulatory submission. Instead of treating compliance as a document exercise, Aras operationalizes it within everyday product development — enabling medical device manufacturers to scale innovation confidently, accelerate approvals, reduce inspection risk, and maintain complete alignment across engineering, quality, and regulatory teams.

The Accelerator consists of a bundle of four templates, each of which is available for separate purchase if the full scope of capability is not required:

• Design Control for Medical Device: Provides structured, phase-based design control aligned to FDA 21 CFR 820.30 and global regulations. Enables end-to-end traceability from user needs through design inputs, outputs, reviews, verification, validation, and transfer. Includes templated DHF, DMR, and Technical File structures with formal evidence capture to ensure audit readiness and predictable compliance execution.

Benefit: Repeatable compliance, reduced manual documentation effort, and faster regulatory submissions.

• Risk Management for Medical Device: Delivers integrated risk management aligned to ISO 14971, embedded directly into requirements, verification, and manufacturing outputs. Supports hazard analysis, DFMEA/PFMEA, explicit linkage of risk controls to design and test artifacts, and visibility into residual risk decisions.

Benefit: Proactive risk mitigation, defensible benefit-risk decisions, and strong alignment between risk activities and design outcomes.

• Advanced Quality Management for Medical Device: Provides closed-loop quality processes integrated across the product lifecycle, including CAPA, nonconformance management, audit management, complaint handling, and change governance. Connects quality events directly to design, risk, and supplier data within a unified system.

Benefit: Reduced compliance risk, faster root-cause resolution, improved inspection readiness, and continuous quality improvement.

• Product Definition & Change Control for Medical Device: Provides product definition and change control capabilities tailored to medical device development and production. This template extends Aras Product Engineering with domain-specific concepts, enabling precise configuration management, faster iteration cycles, and controlled change execution across complex products.

Benefit: Shorter ECO cycles without sacrificing control, fewer late-stage manufacturing disruptions, clear traceability from change request to production implementation

The Aras Medical Device Accelerator addresses the core challenges faced by medical device manufacturers—regulatory complexity, disconnected systems, and compliance risk—by delivering a regulatory-grade digital thread across the product lifecycle.