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RPD International Fast-track to ISO 13485 for medical device product development

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Success Stories

RPD International

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.

With bigger clients and more prestigious projects driving business growth, the time had come for RPD to demonstrate its quality credentials through ISO certification. Increasing interest from the medical devices sector meant that ISO 13485 would be required alongside ISO 9001.

6

Month programme

0

Nonconformities

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Investigation
Advisory
Management systems
ISO certification
Partnering

Implementation

RPD doesn’t do slow. The clue is in the name: Rapid Product Development. Having committed to a fast - track project at the beginning, pressures from their medical device client meant that we had to find a fast-track within the fast-track. QFactorial doesn’t do template systems. We were determined to do something specific for this client’s unique business context and culture. So, quite a challenge!

We started with a leadership workshop to define all the business parameters that would influence the design of the system. A bespoke leadership toolkit was created to gather the output from the workshop and enable the leadership team to build up key parts of the system as part of a collaborative effort. For the overall system design, in keeping with the client’s own mode of operation, we quickly developed an innovative approach. We described the complete business management system (BMS) in a single PowerPoint document written in a conversational style that would serve as a signposting, training and communication tool, whilst also meeting the requirements of ISO 9001 and ISO 13485.

The importance of company culture should not be underestimated when designing a management system. People have to feel comfortable with the style and presentation of the system otherwise they simply won’t engage with its aims or content. As consultants, we must be willing to innovate with our clients and convince external auditors to accept new ways of meeting the standards.

The Outcome

ISO 9001 and ISO 13485 certification were achieved simultaneously with zero nonconformities. Positive comments from the external auditors and the company’s medical devices client confirmed that the BMS was not only aligned with RPD’s strategy and ambitions, but also “impressively implemented and fit for the business.” We were especially pleased that we had managed to meet the standards in a way that suited the youthful and creative culture of the business.

Q! Feedback

“We worked with QFactorial to fast-track our certification for ISO9001 and ISO 13485. It was a fantastic process; QFactorial provided the right level of support and contribution to support our internal team. The process was seamless and our consultant was constantly available for questions and support at all times of the day. We really enjoyed working with QFactorial and consider them part of our team now!”

Josh Valman

Chief Executive Officer

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