Simploud Go (ISO 13485)

Simploud Go ISO 13485 package is developed for Medical Device, Medical Technology and Digital Health companies who want to comply with the ISO 13485:2016 (and ISO 14971:2019) requirements.

Do you have any of the following problems?

I struggle to maintain real-time ISO 13485 or FDA 21 CFR Part 11 compliance because my quality records are paper-based, and audits always feel like a scramble.
Compiling Device History Records (DHRs) takes me weeks, and I’m constantly worried about missing something before an inspection.
My supplier quality management is reactive because I have no integrated way to track performance trends, certifications, or audit history.
I don’t have a centralized way to track critical-to-quality (CtQ) parameters across batches, which makes it harder to detect quality drift.
My environmental monitoring and equipment calibration records are siloed, making it difficult to investigate deviations or adverse events quickly.
I can’t easily perform trend analysis on complaints, returns, or field service reports, which makes it harder to detect systemic product issues early.
I can’t integrate quality data with ERP, PLM, or LIMS systems, which forces redundant data entry and increases the chance of errors.
My audit trails are incomplete or scattered, making it hard to demonstrate control over electronic records and signatures.

My CAPA and Nonconformance processes are scattered across spreadsheets and email, and I can’t easily prove timely, effective resolution to regulators.
My document control relies on shared drives with no true version control, and I’m concerned about outdated SOPs being used on the production floor.
My training management is disconnected from quality events, so I can’t guarantee employees have the latest qualifications when they perform critical tasks.
My quality data is scattered across multiple systems and paper forms, so I don’t have a single source of truth for decision-making.
My current quality processes can’t scale to meet multi-site or global operations without significant cost and risk.
I only feel inspection-ready after an intense period of last-minute preparation, which drains resources and increases the risk of findings.
My slow, manual quality processes delay time-to-market, putting me at a disadvantage compared to competitors with modern, connected QMS systems.

Why Choose SimploudGo?

Instant Deployment – Start fast with pre-built quality management modules.
Fully Validated – Meets 21 CFR Part 11, Annex 11, and GAMP 5 standards.
Scalable & Flexible – Expand as your business grows.
Effortless Compliance – Designed for ISO 13485/14971, GxP, GDPR, and HIPAA.
Paperless Transition – Digitize processes while maintaining full audit trails.

What’s Included?

SimploudGo covers key aspect of the QMS for ISO 13485, providing essential modules such as:

Product Lifecycle

Requirements

Design Input and Output

Risk Management

Test Execution

Traceability Matrix

Validation & Verification Binder

Controlled Documents

General Documents

SimploudGo provides a pre-validated, ready-to-use eQMS with essential modules and built-in best practices to help you achieve compliance effortlessly. If you are not sure which solution to choose, please use our questionnaire to decide:

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Simploud Go (ISO 13485)