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MDS2 Medical Device Security Evidence & Implementation Kit

$249.00
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MDS2 Medical Device Security · Medical device security disclosure, made adopt-ready · Evidence & Implementation Kit
Meet the MDS2 medical device security disclosure, without decoding it yourself.
Every requirement handed to you as an adopt-ready control, data and access controls through encryption, malware and patching to vulnerability disclosure and secure decommissioning, with the evidence a healthcare buyer examines.
Ready in a weekend, not a quarter.

Here is the honest situation. The Manufacturer Disclosure Statement for Medical Device Security (MDS2) is how manufacturers communicate a device's security capabilities to healthcare delivery organizations. It covers the data and ePHI a device handles, access control and authentication, encryption at rest and in transit, audit logging, malware protection and hardening, patching and a software bill of materials, network and remote access, secure configuration and decommissioning, and vulnerability disclosure. A manufacturer that builds a secure device but cannot produce an accurate, current MDS2 or an SBOM is exactly where manufacturers fall short.

This Kit removes the guesswork. It is the MDS2 disclosure written as adopt-ready controls you personalize in a weekend, with the evidence a healthcare buyer examines.

What you get, the moment you buy

18
Requirements as adopt-ready controls. Every requirement, written so you personalize and apply it.
18
Evidence-they-examine checklists. For each control, exactly what a healthcare buyer examines, plus where manufacturers fall short, so you close the gap first.
1
Control Matrix, pre-built. Every requirement in a working spreadsheet, ready to record status, owner and evidence location.
1
Gap & Readiness Assessment. Score each requirement and the workbook returns your readiness as a single percentage, and exactly what to fix next.

Grounded in MDS2 (Manufacturer Disclosure Statement for Medical Device Security). Editable Word and Excel files.

Buyers decide on the MDS2, so it must be accurate and current
Healthcare buyers assess device security from the MDS2, increasingly alongside a software bill of materials and vulnerability disclosure. An outdated or thin statement loses the sale and the trust. This Kit turns the MDS2 disclosure into controls with the evidence a healthcare buyer asks for.

What one control looks like

This is the first control, where the framework begins. All 18 are built to this depth.

MDS2-1 Adopt MDS2 for device security disclosure SCOPE
Put this control in place

Adopt the Manufacturer Disclosure Statement for Medical Device Security (MDS2) at [your organization name] to disclose the security capabilities of each medical device, completing an accurate statement per device model and version, and document it, so security capabilities are disclosed and the organization can evidence its MDS2.

Framework note.

The MDS2 is the standard form used to communicate the security-related features of a medical device to healthcare delivery organizations.

Evidence a healthcare buyer examines
  • A completed MDS2 per device
  • Model and version identified
  • Records of the statements
Common finding they raise: Medical device security capabilities are not disclosed via MDS2.

Why this is not another template pack

  • The evidence is the point. A requirement you cannot evidence is a finding waiting to happen. This tells you what a healthcare buyer examines and where manufacturers fall short, for every requirement.
  • The substance built in. The core requirements are written into the controls, not left as principles.
  • Built on a mapped compliance corpus, not one person's opinion, from a graph of thousands of controls across standards.
  • It compounds. This framework aligns with your wider compliance program, so the work feeds other standards.

Who buys this

Organizations subject to this framework and their relevant leads. Whether it is a first alignment or a readiness pass, you save weeks and walk in with the requirements structured.

By the end of the weekend you will have
✓  An adopt-ready control for all 18 requirements
✓  A completed control matrix
✓  The evidence a healthcare buyer examines
✓  Your core controls in place
✓  A readiness percentage and a fix list
✓  The remaining gaps closed

Common questions

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

Is this an official MDS2 form? No. It is an independent implementation toolkit grounded in the MDS2 disclosure and medical device cybersecurity expectations, to get your capabilities and evidence in order fast.

Does it help me self-assess? Yes. The Gap and Readiness assessment scores you against the requirements and ranks the fixes.

Is this legal advice? No. It is an implementation toolkit grounded in the framework. For a specific matter consult a qualified adviser; this gets your controls and evidence in order fast.

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

Do not face an assessment with requirements you cannot show.
Every requirement is fast to adopt with the Kit. It is instant, and it is guaranteed.
Add it to your cart and be 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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