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To find out more about how Qfactorial can help your business, please get in touch using the enquiry form below or, if you prefer, call us on +44 (0)1256 814111 or email kevin@qfactorial.co.uk to speak to our principal consultant.

Success Stories

Regulatory support for consumer products and medical devices.

RPD International develops new products for consumer markets and industrial applications. From its head office in London, RPD helps its clients to realise their product ideas by designing, testing, and setting up the manufacturing, supply chain and logistics to bring the product to market.

QFactorial has been working with RPD since 2018, including several new product developments, usually for tech start-ups. We provide expertise to help RPD’s client ensure that their product meets the regulatory requirements to enter UK and International markets. Our input is an analysis of the regulatory requirements for each territory with advice on how to meet them. We do this as an integrated part of the project team.

6

Products.

4

Territories (UK, EU, US & AUS).

QFactorial Service offering

ISO Certification
UKAS Accreditation
Sustainability Strategy
Process Improvement
Audit Services
Advisory Services

Implementation

When RPD set up a project for a new product and ask Q! to assist, we’re usually tasked with creating the regulatory matrix. This provides a comprehensive analysis of the regulatory requirements for the product, in each territory, in which it is to be marketed. Typically, this includes UK, EU, USA FDA and the MDSAP region regulatory requirements which compliment ISO 13485. For medical devices, this includes requirements for the device to be approved by MDR, UK MDR, IVDR, UK CA marking, CE marking and FDA.

We begin by completing a scoping activity which allows us to understand the goals and objectives of the project, but also the technical requirements and the functioning of the product itself. We look at the intended users alongside the technical engineering of the product and how these could be applied to its compliance requirements, directives and regulations. From here we’re able to provide support for specific Q&A topics, help to identify compliance needs for the various intended markets, assist with regulatory strategy, help with device classification, define the classification rationale, and help the client to select the most appropriate conformity assessment route.

It’s exciting to be working with a company whose products show such a high level of innovation and are on the cutting edge of medical technology – a big nerdy tick! Supporting the next generation of medical knowledge and the international reach of the products, many of which offer unique health care innovations, is work we take a real pride in.

The Outcome

We’ve worked together with RPD on many of their projects since 2018, and indeed are still working with them now, which makes it hard to speak in terms of single outcomes. However, for each project we have ensured that the products have been “designed for compliance” right from the get-go. Documentation was produced in line with their ISO 13485 QMS (which we had developed previously), and these were then leveraged against the Regulatory Matrix to develop the product specifications (technical and otherwise). This way there could be no danger of reaching the end and being sent back to the drawing board because something, somewhere, was not compliant. 6 products and 4 territories later, the biggest outcome for us is a strong partnership with our client.

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Q! Feedback

A cornerstone of helping our clients bring innovation to market is robust regulatory compliance, and Q Factorial are a pivotal partner to RPD to ensure we are meeting compliance obligations and gaining regulatory approval.

We have also worked with Q Factorial on our own ISO certification - from building our BQMS through to audit support, they have been by our side to make what is an onerous and difficult process manageable and even fun!

Jacelyn Meller

CCO

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