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IEC 62304:2015 Medical Device Software Life Cycle Evidence & Implementation Kit

$249.00
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IEC 62304:2015 · Medical Device Software · Evidence & Implementation Kit
Get your medical device software through the notified body, with the lifecycle evidence IEC 62304 requires.
Every IEC 62304 lifecycle requirement handed to you as an adopt-ready control, with the safety-class nuance, the exact evidence an auditor examines, and the finding they most often raise.
Audit-ready in a weekend, not a quarter.

Here is the honest situation. IEC 62304 is the gate for medical device software, and notified bodies examine the lifecycle records closely. The hard part is producing them: a development plan, requirements, architecture with item segregation, a SOUP list, verification at each stage, risk management handing off to ISO 14971, configuration management and problem resolution, all scaled to the software safety class. A consultant charges heavily and doing it yourself is months while your submission waits.

This Kit removes the build. It is the complete IEC 62304 lifecycle requirement set and evidence guide that you personalize in a weekend.

What you get, the moment you buy

30
Requirements as adopt-ready controls. Every lifecycle requirement across classification, development, maintenance, risk management, configuration management and problem resolution, scaled to the software safety class. Personalize and you are done.
30
Evidence-they-examine checklists. For each requirement, exactly what an auditor examines, plus the finding they most often raise, and the safety-class nuance that catches manufacturers out.
1
62304 Control Matrix, pre-built. Every requirement in a working spreadsheet, ready to record your implementation, status and evidence location.
1
Gap & Readiness Assessment. Score each requirement and the workbook tells you your readiness as a single percentage, and exactly what to fix next.

Built for medical device software to the IEC 62304 structure, with the A/B/C safety class scaling, SOUP handling, item segregation, and the ISO 14971 and ISO 13485 hand-offs called out. Editable Word and Excel files.

The safety class drives everything
IEC 62304 scales its requirements by software safety class. Class A needs less; Class C, where software could contribute to death or serious injury, needs the full lifecycle. This Kit is built around getting the classification right first, because the required activities and records all follow from it.

What one control looks like

This is clause 5.3, developing the software architecture from requirements, where item segregation for risk control is decided. All 30 are built to this depth.

5.3 Develop the software architecture from requirements SOFTWARE DEVELOPMENT
Adopt this requirement

[Manufacturer] shall transform the software requirements into a documented architecture describing the software items, their interfaces to each other and to hardware and external software, and how the architecture supports the required functional and performance behaviour. Verify that the architecture implements the software requirements, that interfaces are defined, and that it can support the risk control measures assigned to software.

Evidence an auditor examines
  • The software architecture document
  • The description of software items and their interfaces
  • The architecture verification record
  • Traceability from software requirements to architecture
Common finding they raise: Architecture diagrams exist but interfaces between items and to external systems are undocumented.

Why this is not another template pack

  • The evidence is the point. Generic software templates ignore medical devices. This tells you exactly what an auditor examines and the finding they raise, for every requirement, scaled to the safety class.
  • Written for medical software. Safety classification, SOUP handling, item segregation, and the ISO 14971 risk and ISO 13485 record hand-offs are built in, not bolted on.
  • Built on a mapped compliance corpus, not one person's opinion, from a graph of thousands of controls across standards.
  • It compounds. IEC 62304 sits with ISO 13485 and ISO 14971, so your quality, software and risk work share one evidence base.

Who buys this

Medical device manufacturers and their software teams, regulatory and quality leads owning the software lifecycle, and consultants preparing device makers for certification. Whether it is a first submission or a change, you save weeks and walk in with the lifecycle records ready.

By the end of the weekend you will have
✓  A requirement for every IEC 62304 process
✓  A completed 62304 control matrix
✓  The evidence an auditor examines
✓  Your safety classification and SOUP list anchored
✓  A readiness percentage and a fix list
✓  The common findings closed before the audit

Common questions

Is it really editable? Yes. Word and Excel files you own and adapt. No portal, no subscription.

Does this certify me? Conformance is assessed by a notified body or auditor. The Kit gets you ready: the requirements, the matrix, and the exact evidence they examine, across every process.

Does it handle safety classes? Yes. Every requirement notes how the A, B or C safety class scales what you must do, and classification is built in as the first step.

Does it cover SOUP and risk? Yes. SOUP handling and the ISO 14971 risk-management hand-off are covered, along with configuration management and problem resolution.

What if it is not for me? A 30-day money-back guarantee.

Do not let the software lifecycle hold up your submission.
A consultant is a heavy fee and months. The Kit is instant, and it is guaranteed.
Add it to your cart and be audit-ready this weekend.

Instant digital download · 30-day money-back guarantee · The Art of Service Pty Ltd, GPO Box 2673, Brisbane QLD 4001 · support@theartofservice.com

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