RPD International

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

Client Challenge

RPD International (now RPDK) turns product ideas into reality, designing, testing and setting up manufacturing and supply chains for consumer and industrial clients across multiple markets.
Bigger clients and growing medical device interest meant RPD needed to prove its quality credentials fast, and prove them again for every new product and territory that followed.
Regulatory support for consumer products and medical devices.

“QFactorial provided the right level of support to our internal team. The process was seamless and we consider them part of our team now.”

Key challenges included:

Aggressive client deadline for ISO 9001 and ISO 13485 certification

ISO 13485 needed to support NPD and regulatory approval

Youthful, creative, fats-track culture that standard templates wouldn’t fit

Multiple products marketed in diverse territories with regulatory complexity

Compliance to be baked in from the earliest product design stage

Outcomes achieved

ISO 9001 and ISO 13485 achieved simultaneously

Zero nonconformities across both standards

Regulatory support embedded across six products

Four territories navigated: UK, EU, US, Australia

Project support resolved into ongoing partnership

Gosh, you shouldn’t have…

Kind words from our clients

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