FSSAI — Nutraceuticals
Can I sell this as a health supplement, and what am I allowed to claim on the label?
ISO 13485 quality management system readiness
What does a device QMS need to contain, and are we audit ready?
What this route requires
ISO 13485 sets quality management system requirements for organisations involved in the design, production, installation and servicing of medical devices.
A certified QMS is a practical prerequisite for most device market access: notified bodies and several regulators expect it, and it underpins the design controls and traceability that a technical file depends on.
The common failure is a QMS written to pass an audit rather than to describe how the organisation actually works — which then diverges from practice within months.
Applies to
Organisations designing or manufacturing medical devices.
Our scope
How Prequel supports it
- Gap assessment against the standard
- Process and document matrix mapped to your actual operations
- Audit-readiness planning and mock audit support
- Linkage between QMS processes, design controls and the technical file
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 13485 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.