ISO 14971
How do I connect hazards to controls, and controls to evidence?
ISO 13485 quality management system readiness
What does a device QMS need to contain, and are we audit ready?
- AuthorityISO 13485
- JurisdictionInternational
- Type Supporting standard
- Our scopeDelivered by Prequel
What this route requires
ISO 13485 sets quality management system requirements for organisations involved in the design, production, installation and servicing of medical devices.
ISO 13485-aligned QMS requirements are important across many medical-device markets, but certification and evidence expectations vary by jurisdiction and route. A conforming system underpins the design controls and traceability a technical file depends on, whoever is asking for it.
In the United States the position is specific: FDA’s Quality Management System Regulation incorporates ISO 13485:2016 by reference, but FDA does not require manufacturers to hold ISO 13485 certification and will not accept a certificate in place of its own requirements or inspection.
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.
CDSCO — India
What class is my device under Indian rules, and what does CDSCO need from me?
510(k) — US FDA
Which predicate do I claim, and what evidence proves substantial equivalence?
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.