Who We Serve: Technology
Wearables and Digital Health
Wearables and connected health products are built like consumer electronics and regulated, at least in part, like medical devices. The tension shows up in marketing claims, update cadence and a supply chain chosen for cost and speed. We help digital health companies build quality records that hold up under both.
Standards and Regulations to Know
- IEC 60601-1-11Medical Electrical Equipment in the Home Healthcare Environment
- IEC 60601-1-2Electromagnetic Compatibility of Medical Electrical Equipment
- IEC 62304Medical Device Software Lifecycle Processes
- IEC 81001-5-1Security Activities in the Health Software Lifecycle
- IEC 62366-1Usability Engineering for Medical Devices
- ISO 10993-1Biological Evaluation Within a Risk Management Process
- ISO 14971Risk Management for Medical Devices
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
Typical Regulatory Exposure
Whether a product is a device depends on its intended use, which FDA reads from labeling, marketing and the claims a company makes. FDA has described a policy for low-risk general wellness products, and many digital health companies offer wellness features and regulated functions on the same hardware. The line between them has to be drawn deliberately and defended in the design and change records.
A typical product is a system: a body-worn sensor, firmware, a mobile app and a cloud service. IEC 60601-1-11 covers medical electrical equipment used in the home, IEC 60601-1-2 covers electromagnetic compatibility, IEC 62304 and IEC 81001-5-1 cover the software lifecycle and its security, and IEC 62366-1 covers usability for lay users. Prolonged skin contact brings biological evaluation under the ISO 10993 series.
Hardware often comes from a contract manufacturer whose component suppliers change frequently. Purchasing controls, change notification and incoming verification are where a consumer electronics supply chain most often collides with medical device expectations, and firmware delivered over the air needs the same release control as any other design change.
Where Audits Find Gaps
- 01
Marketing Claims Ahead of Authorization
Website copy, app store listings or sales materials describe a medical function the product has not been cleared or authorized for, or describe wellness features in diagnostic language.
- 02
Component Substitutions Without Notice
The contract manufacturer substitutes components for availability or cost, and the quality agreement does not require notice or approval before the change.
- 03
Over-the-Air Updates Without Release Records
Firmware and app updates ship through automated pipelines with no QMS record tying each released version to its verification and change assessment.
- 04
Regulated and Wellness Functions Not Separated
The design file does not show which software functions are regulated and which are not, so changes to shared code are not assessed for their effect on the regulated function.
- 05
Battery and Skin Contact Risks Underexamined
The risk analysis covers the algorithm in detail but treats battery heating, charging and prolonged skin contact as consumer electronics issues outside the risk file.
Relevant Standards and Regulations
- IEC 60601-1-11Medical Electrical Equipment in the Home Healthcare Environment
- IEC 60601-1-2Electromagnetic Compatibility of Medical Electrical Equipment
- IEC 62304Medical Device Software Lifecycle Processes
- IEC 81001-5-1Security Activities in the Health Software Lifecycle
- IEC 62366-1Usability Engineering for Medical Devices
- ISO 10993-1Biological Evaluation Within a Risk Management Process
- ISO 14971Risk Management for Medical Devices
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
Relevant Services
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
Supplier Audits and Supplier Controls
Risk-based supplier selection, quality agreements, monitoring and supplier audits that hold up under QMSR.
Software Validation and Device Software (CSV, IEC 62304)
Validate software used in production and the QMS, and build device software on an IEC 62304 lifecycle.
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
QMS Build for Startups (Phased)
A QMS built in phases for a device startup: design controls and risk first, the rest before you need it.
Audits and Inspections You May Face
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
ISO 13485 Certification Audit (Stage 1 and Stage 2)
The Stage 1 and Stage 2 audits a certification body runs before granting ISO 13485 certification.
Supplier Audit
Audits you perform of your own suppliers and contract manufacturers as part of purchasing controls.
Questions
How do we know whether a wearable feature is a medical device?
It turns on intended use: what the feature is for and what you claim it does. FDA has described a general wellness policy for certain low-risk products, but claims about diagnosing, treating or managing a disease generally point toward device regulation. That determination belongs to your regulatory team or counsel, and we help make sure your records reflect it consistently.
Can one product have both regulated and unregulated features?
Yes, and many do. The design and change records need to show where the boundary sits, so that a change to shared hardware or code is assessed for its effect on the regulated function.
What should our quality agreement with a contract manufacturer cover?
Change notification and approval, component sourcing, nonconforming product, access to records and your right to audit, at a minimum. For manufacturers new to medical devices, it also helps to spell out which of their usual practices need to change.
Wearables and Digital Health
Get an Advisor's View of Your Quality System
Tell us about your devices and the audit or inspection ahead, and an advisor will scope an assessment for your kind of product. Please don't send confidential documents yet: secure upload is set up after onboarding.
