Policy development · Digital health & life sciences
Privacy & Security Policy Development for Medical Device Makers
Policy development for a device maker means writing patch, retention and companion-app policies that a hospital CISO will accept and an ISO 13485 auditor will recognize as part of your existing quality system, rather than a second, competing set of documents. Work usually starts when an auditor flags a gap in software-lifecycle documentation, or when a support team realizes nobody has written down how long a service log with patient data may be kept. We write policies that dock into your document control instead of sitting outside it.
Reviewed by the Privacy Horizon team · Last reviewed
What you're protecting
What has to be written down, not assumed
The gaps a policy review usually finds are less about missing intentions and more about intentions nobody wrote down consistently.
Secure development and patch management
Commitments covering how security is built into firmware and cloud releases, and how patches reach a fleet that may include devices several years past their original release.
Data retention for service and complaint records
How long service logs, screenshots and MDR narratives containing patient information are kept, and when they are securely disposed of, balanced against regulatory record-keeping duties.
Companion-app privacy notice and consent
Clear language for patients and caregivers about what monitoring data is collected, how it is used, and how consent for ongoing telemetry differs from a one-time interaction.
Supplier and component security requirements
Written expectations for contract manufacturers and component suppliers, so security terms exist in writing before a hidden-functionality finding forces the question.
Regulatory map
Why these policies have to satisfy two readers at once
The same document set gets read by an ISO 13485 auditor checking process control and a hospital security team checking risk.
ISO 13485 documented procedure requirements
Section 32 certification requires documented quality management procedures, and security-related policies need to fit inside that structure rather than exist as a parallel, unreferenced set.
Health Canada's expectation that security processes be described
Premarket cybersecurity guidance expects manufacturers to describe how security is built into design and risk management, which is easiest to demonstrate when the underlying policies already exist and are followed.
PIPEDA and PHIPA retention and use-limitation principles
Data-retention policy has to reflect the principle that personal information, including telemetry and complaint narratives, is kept only as long as the purpose or a regulatory requirement justifies.
What goes wrong
What clear policy prevents
Most of what a policy review catches is inconsistency, not malice, and inconsistency is exactly what auditors and hospital reviewers notice first.
Inconsistent patch commitments across an aging fleet
Without a written policy, patch timelines get negotiated ad hoc with each hospital customer, creating commitments engineering cannot reliably keep and a support burden nobody planned for.
Complaint narratives retained indefinitely
A complaint-management system with no retention policy accumulates patient narratives well past any regulatory or operational need, expanding what a future breach would expose.
Ad hoc hospital-facing security commitments
Sales and support teams making informal security promises to different hospitals, unaware of what engineering can actually deliver, until two customers compare notes.
Our policy development for medical device makers
What our policy development covers for a device maker
Policies written to reflect how your engineering and RA/QA teams actually operate, then aligned to your existing document control.
Secure development and patch policy
A policy describing how security requirements enter the design process and how patches are prioritized, tested and delivered across current and legacy hardware.
Data retention and minimization policy
Retention schedules for telemetry, complaint files and service logs, distinguishing what regulatory record-keeping requires from what can be safely disposed of.
Vendor and supplier security policy
Expectations placed on component suppliers, contract manufacturers and cloud sub-processors, written so they can be referenced in supplier agreements.
Companion-app privacy notice
Patient- and caregiver-facing language covering what is collected, how consent works for ongoing monitoring, and how to withdraw it.
Alignment mapping to ISO 13485 documentation
Each policy cross-referenced to your existing SOP numbering so auditors and internal teams can find it where they already look.
How the engagement runs
How policy development runs alongside your QMS
We start by seeing what you already have, since duplicating an existing ISO 13485 procedure wastes everyone's time.
Step 1
Inventory existing QMS documentation
We review current SOPs to identify what already exists, what is outdated, and where a true gap sits.
Step 2
Draft policies against regulatory and operational hooks
New or revised policies are written to satisfy ISO 13485 documentation expectations and the applicable privacy principles at once.
Step 3
Review with engineering, RA/QA and support
Draft policies are checked against what teams can realistically commit to, since a policy nobody can follow creates its own audit risk.
Step 4
Publish inside your document control system
Final policies are versioned and filed within your eQMS alongside existing procedures, not as a standalone set easily forgotten.
What it costs
What determines policy development cost here
Cost depends on how much of your existing ISO 13485 documentation can be extended versus written from scratch, how many distinct product lines and hardware generations need patch-policy coverage, and how many jurisdictions your retention policy has to account for.
Policy development is also delivered as part of a Virtual Privacy Office retainer, where policies are kept current as regulations, hospital expectations and your product line change. We quote after reviewing your current QMS document set.
Medical Device Makers: Policy development questions, answered
Auditors want to see a documented procedure that fits your existing quality system, with clear ownership and traceable records. Hospital CISOs want to see realistic patch timelines and a communication commitment for known vulnerabilities. A policy written to satisfy both covers process, ownership and customer-facing communication in one document.
It should state how long logs are kept, tied to a specific operational or regulatory reason, who can access them, and how they are disposed of securely once that period ends. Field-service logs that incidentally capture patient information need the same discipline as any other record holding personal health information.
They should be written to extend or reference your existing SOPs wherever one already partially covers the topic, rather than exist as a separate, competing document set. Duplication is the fastest way for a policy to be ignored by the team that already follows the original procedure.
Start by classifying your installed base by hardware generation and update capability, then set differentiated commitments, some devices can receive OTA patches quickly, others require a service visit. The policy should be honest about which category each product line falls into rather than promise uniform speed.
It needs to explain ongoing physiological monitoring in plain language, distinguish consent for continuous data collection from a one-time interaction, and address who else, a clinician, a hospital, a family member, may see the data. A generic app privacy policy rarely addresses continuous health monitoring clearly enough.
At minimum, whenever your product line, hardware generation or hosting arrangement changes, and whenever an audit or regulatory guidance update touches software or cybersecurity expectations. Most device makers review policies annually and after any significant product or regulatory change.
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