Penlon Case Study:
Transition to ISO 13485:2016

Penlon’s core business is the design, development and manufacture of anaesthesia equipment and other complementary life support products primarily for use in operating theatres.

Penlon Senior Management recognises the significance of certification to ISO 13485:2016 and made a strategic decision to invest in the transition relatively quickly, although they had the challenge of changing Certification and Notified Body within the same year of their transition to EN ISO 13485:2016.

Stuart Franklin, Managing Director, Finance & Operations commented, “EN ISO 13485:2016 is an essential component of the many certifications that we need in order to gain the trust and respect of our firm’s broad stakeholder group. The standard is already becoming an essential requirement for many international medical device tenders and is a distinct competitive advantage to the business. The journey towards the revised standard along with the internal audit training, offered a wider cross-functional engagement which supported a smooth process of our implementation. The Executive Management Team is delighted that we made the move to LR and we feel assured that this partnership will continue to grow in future years”.

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