Manufacturing or Healthcare and Medical

Penlon manufactures and distributes medical products and systems for anaesthesia, intubation, oxygen therapy and suction. The company’s largest customer in the UK is the NHS and Penlon also markets to the UK private sector. Internationally, customers include hospitals, clinics, governments and the pharmaceutical industry. Penlon exports to over 90 countries, with representative offices in China, Japan and the US.

Our client has a long-standing reputation for product innovation and manufacturing quality, from raw materials to finished assembly. Established out of Oxford University in 1943, Penlon holds ISO 13485 accreditations, CE marking and FDA clearance for its medical devices, alongside other global licences. The company’s efforts have been recognised by royal warrant on numerous occasions, winning the Queen’s Award for both enterprise and innovation.

As an organisation committed to providing affordable, appropriate healthcare, Penlon’s senior management team recognised the significance of gaining certification to the latest ISO 13485:2016 standard. Following an internal, three-month gap analysis, the business made the strategic decision to invest in the transition (from ISO 13485:2012) and was keen to complete this project early. Focus could then continue on research and new product development. At the same time, the company had the challenge of changing Certification and Notified Body, approaching us as a leader in quality assurance to support a smooth implementation process.

Following a gap analysis, Penlon knew that implementing EN ISO 13485:2016 required relatively small adjustments to its quality management system (QMS) system. Having consulted functional managers and agreed the implementation date, Penlon asked us to deliver internal auditor training, bringing the team up to speed on understanding the changes to the revised standard and meeting the latest requirements.

From the project’s outset, we worked closely with the Penlon team to communicate the right messages across the business and provide technical support, as needed. We helped Penlon to engage and involve functional heads and senior management, achieving company-wide buy-in to the transition. We then delivered auditor training in-house, customised to our client’s needs and in line with Penlon’s strategic plans. 12 employees across functions attended the two-day programme.

Penlon researched a number of Certification Bodies before choosing us and have shared some tips. The company suggests that organisations looking to transfer to a new Certification Body should consider:

• the scope of the Certification Body’s accreditation so it fits your requirements, giving confidence that your full suite of products and possible future products are covered
• the status of yourISO 13485:2016 accreditation under UKAS, indicating that your quality system in place is consistent, traceable and up to date Please sense-check
• that the Certification Body will follow a pragmatic approach to transferring certification within the certificate cycle
• the Certifications Body’s responsiveness during the review process, so you can create a clear plan
• any positive feedback from industry on timeliness and technical file scheduling; a key element of any product launch that your timescales will be met Please sense-check
• whether the Certification Body is active at the UK Medical Device Trade Association, suggesting that they listen to clients and keep up to date with industry trends, changes and regulatory developments
• whether the Certification Body has pragmatic and competent auditing resource
• the availability of relevant training programmes, so employees can attend courses that will help you implement and maintain your quality management system (QMS)

the Certification Body’s participation within theMedical Device Single Audit Program (MDSAP) scheme as an eligible auditing organisation – future proofing your global compliance requirements under one scheme

The internal auditor training has helped Penlon’s cross-functional team perform internal audits to the new ISO 13485:2016 standard, with a quality management system (QMS) that underpins the company’s systems and processes.

Certification has reinforced the company’s commitment to quality and putting the patient first. The standard is already becoming a key requirement for many international medical device tenders, providing Penlon with a distinct competitive advantage when bidding for new business, domestically and internationally.

Penlon’s specialist team is now free to start preparing for other transitional changes, including  those around the European Medical Device Regulation (MDR) and Medical Device Single Audit Program (MDSAP).