FSSAI — Nutraceuticals
Can I sell this as a health supplement, and what am I allowed to claim on the label?
ISO 14971 risk management for medical devices
How do I connect hazards to controls, and controls to evidence?
What this route requires
ISO 14971 specifies a process for managing risk across the medical device lifecycle: identifying hazards, estimating and evaluating risks, controlling them, and monitoring the effectiveness of those controls.
Its practical value is traceability. Every identified hazard should connect to a control, every control to the verification or clinical evidence that shows it works. That chain is what a reviewer follows, and gaps in it are what they find.
Applies to
Any device programme; a prerequisite for MDR, FDA and ISO 13485 alike.
Our scope
How Prequel supports it
- Risk management plan and file structure
- Hazard identification and risk evaluation
- Risk control definition and residual risk assessment
- Traceability from hazards through controls to V&V and clinical evidence
Delivered by Prequel. Where a step needs a specialist partner — laboratory testing in particular — we define the scope and review the output, and we say so rather than implying it is in-house.
Other routes
Many programmes target more than one market. Evidence generated for one route can often support another, which is worth planning before testing starts rather than after.
AYUSH — ASU products
What licence does an Ayurvedic or herbal product need, and who issues it?
CDSCO — India
What class is my device under Indian rules, and what does CDSCO need from me?
Not sure ISO 14971 is your route?
That is what the Readiness Assessment settles. Tell us the product, its intended use and your target market, and we will confirm the pathway before you commit to evidence.