ISO 13485
Quality management systems for medical devices — the framework governing how we design, document, and control development so decisions are traceable and repeatable.
Clinical & regulatory
A grounded path to the bedside.
VeinMate Assist is in development. Our regulatory strategy is deliberately conservative — because keeping the clinician in control keeps the pathway clear.
Regulatory pathway
Regulatory pathway
Forest Bloom is pursuing a CDSCO Class B medical-device pathway in India. The clinician-executed design is a deliberate choice: it keeps VeinMate Assist positioned as a guidance device rather than an autonomous one, which materially simplifies classification and shortens the route to clinical use.
VeinMate Assist is an investigational device. It is not yet approved for sale or clinical use. Nothing on this site should be read as a claim of regulatory clearance.
Standards we build to
Standards we build to
We develop against recognised medical-device standards from the outset, so that quality, risk, safety, and biocompatibility are engineered in rather than retrofitted. Formal testing and certification proceed alongside our clinical program; we do not claim any of these standards has yet been passed or certified.
ISO 14971
Application of risk management to medical devices — a structured process for identifying, evaluating, and mitigating hazards across the product lifecycle.
ISO 10993
Biological evaluation of medical devices — the basis for assessing the biocompatibility of any material that contacts a patient's skin.
IEC 60601
Medical electrical equipment — the standard for basic safety and essential performance of the electronics, including electrical and EMC considerations.
Designing to a standard is not the same as certification against it. Testing and certification are in progress.
By design
Why clinician-executed matters for regulation
VeinMate Assist images and guides; the clinician performs the access. That is a deliberate design choice, not a limitation. By keeping a trained clinician in control of every puncture, the device stays a guidance tool rather than an autonomous one — which keeps its classification straightforward and its regulatory pathway grounded.
Autonomy would raise the regulatory bar, the risk profile, and the burden of proof. We have chosen the opposite path on purpose: assist the clinician, keep the decision human, and keep the route to the bedside clear. Even so, the device remains investigational and is not approved for sale or clinical use.
Intellectual property
Intellectual property
- Design patent Granted
- Registered with the Government of India (Reg. No. 474591-001, issued 20 May 2026).
- Utility patent Pending
- A utility patent application covering core aspects of the system is filed and under examination. It has not been granted.
We state patent status precisely: the design patent is granted, the utility patent is pending. We do not blur the two.
Clinical program
Clinical program
Our near-term focus is building the next engineering model and gathering pilot data with clinical partners, followed by the biocompatibility, EMC, and safety testing required for CDSCO submission. Pilot work is how we move engineering targets toward validated performance — under real clinical conditions, with clinicians in control.
Roadmap
Our path to the bedside
This is the pathway we are planning, not a record of milestones already achieved. Each step gates the next.
1
Build the next engineering model
Advance the prototype toward a robust engineering model built with production-grade components, ready for structured evaluation.
2
Gather pilot data with clinical partners
Work with clinical sites to collect real-world data on how the guidance performs in practice, with clinicians executing every access.
3
Biocompatibility, EMC & safety testing
Complete the formal testing required to demonstrate biological safety, electromagnetic compatibility, and essential performance.
4
CDSCO submission
Compile the evidence and file for the CDSCO Class B pathway. Approval for sale or clinical use would follow only after this process concludes.
Our ethos
How we talk about claims
Trust in a medical device begins with how honestly its maker describes it. These are commitments we hold ourselves to in everything we publish.
- Targets are labelled as targets — engineering goals under validation, never proven outcomes.
- Prototypes are called prototypes. We do not dress development hardware up as a finished product.
- Pending is pending. The utility patent is filed and under examination; only the design patent is granted.
- No autonomy claims. The clinician performs the access; the device guides, and we say so plainly.
- No unproven performance figures. We do not publish clinical results the device has not yet earned.
Questions
Frequently asked
Is VeinMate Assist approved?
No. VeinMate Assist is an investigational device and is not approved for sale or clinical use. It is on a CDSCO Class B pathway that is currently in progress.
Is the patent granted?
The design patent is granted (Government of India, Reg. No. 474591-001, issued 20 May 2026). The utility patent is filed and pending examination — it has not been granted.
Which standards do you follow?
We develop against ISO 13485, ISO 14971, ISO 10993, and IEC 60601. Formal testing and certification against these standards are ongoing, not yet complete.
Can we run a pilot?
Yes — we are actively looking for clinical partners to help gather pilot data. Get in touch through Partner with us to start the conversation.
Are the performance figures clinical results?
No. Any performance figures we reference are engineering targets under validation, not proven clinical results.
Partner with us
Partner on a clinical pilot.
If you are a clinical site or medtech partner ready to help gather pilot data, we would like to talk.
Request a briefing