Buy ready-to-use QMS systems for self-implementation, or work directly with us if you need expert support, faster execution, or audit defence.
Get consultant-grade templates, registers, checklists, and system packs built for real medical device quality systems.
Bring us in when you need a sharper implementation path, stronger audit preparation, or expert support on complex compliance work.
Not sure which route fits best? Start with the kits, or book a call and we’ll point you to the right implementation path.
Start with free resources, buy focused execution packs, or go straight to a full QMS system. Every option is structured for real medical device implementation.
One-time purchase. Instant digital access. No recurring licence fees.
Free
Low-friction entry point
Download practical free templates and lead magnets to assess your current system, understand audit expectations, and see the standard of documentation before you buy.
From $69
Clause-level support without buying a full system
Ideal for companies that need immediate help with a specific clause, procedure, checklist, or training need without committing to a larger build.
$499–$599 range
Built for teams actively building or repairing their QMS
These packs cover real operational workflows such as CAPA, internal audit, supplier control, complaints, PMS, and design controls.
$1,290
Premium self-implementation offer
These role-specific systems are built for companies that want a structured ISO 13485 operating model without starting from scratch.
Up to $1,599
Deepest toolkit coverage in one package
For buyers who want broader documentation coverage across design controls, risk, CAPA, supplier controls, records, and regulatory structure in one purchase.
If you are dealing with a live audit, remediation pressure, complex devices, or do not want to self-implement alone, book a consultation and we will point you to the right package or build path.
Yes. The systems are structured directly against ISO 13485 requirements, including clause mapping, required procedures, records, and system interactions.
They are designed to give you an audit-ready framework aligned with how auditors expect to see a quality management system implemented.
Final compliance depends on how the system is implemented within your organisation, but the structure itself is built to support certification readiness.
Yes. All files are fully editable in standard formats (Word and Excel).
You can:
Nothing is locked, restricted, or subscription-based.
Yes. The systems are built to align with:
They provide the documentation structure expected across these regulatory environments, which can then be adapted to your specific device and jurisdiction.
These systems are built based on real audit expectations and regulatory structures.
However, regulators and Notified Bodies do not “approve templates” — they assess:
These templates give you a strong, audit-ready foundation, but acceptance depends on correct implementation and evidence.
These systems are used by:
They are especially useful for teams that want to move quickly without starting from scratch.
Not always.
If you:
These systems can replace a large portion of consulting work.
If you are dealing with complex products, tight timelines, or audit pressure, consulting support can still accelerate implementation.
Most teams begin implementing immediately after download.
Typical timelines:
The templates significantly reduce build time compared to starting from scratch.
Each product includes a structured set of:
Higher-tier systems include complete process frameworks and interlinked documentation structures.
Yes. All products are a one-time purchase.
You get:
