Sector:

New Product Development

Getting a new product to market? We can help.

Structure that enables innovation rather than strangling it.

New product development businesses face a specific challenge. The regulatory requirements are real, but the pace of concept development rarely allows time to stop and build a management system from scratch.

We support:

Why QFactorial?

We know new product development is different.

New product development is iterative, fast-moving and often chaotic. A management system that ignores that reality will not be used. We build quality into your existing development process rather than creating a parallel bureaucracy alongside it. That means design controls that fit your workflow, document management that does not slow down your engineers and certification your team sees as an asset.

We understand:

The step up to (say) ISO 13485 from ISO 9001
Design controls and design/device files
Risk management through the product lifecycle
Supplier qualification and purchasing controls
Regulatory submission preparation

Relevant standards

From medical device quality management under ISO 13485 to broader quality and environmental standards, we help organisations implement the certifications that support successful new product development.

Sector relevant case studies

Client: Thornbury Manufacturing

A three-year ISO 13485 partnership that resolved into mentoring TML’s own internal audit team

Read more
Regulatory support for consumer products and medical devices.
Client: RPD International

Long-term partnership: from fast-track ISO 9001/13485 certification to embedded regulatory support across multiple products and territories

Read more

Gosh, you shouldn’t have…

Kind words from our clients


Ready to bring your product to market with confidence?

Tell us what you’re developing and where you are in the journey. We’ll help you build the right quality systems without slowing innovation.

Our Services: