Head of Certification Body (Medical and Health Services UK)
Head of Certification Body (Medical and Health Services UK)
Head of Certification Body (Medical and Health Services UK)
Tell us about yourself
I have an undergraduate degree in Polymer Materials Science from the University of Manchester and a PhD in Biomaterials from Queen Mary, University of London. I have worked in a number of roles including a Laboratory Assistant in a Quality Assurance Lab at a medical device manufacturer, a Design Engineer developing novel drug delivery devices at an SME, a Laboratory Manager for Materials Characterisation at a University, and most recently as a Product Specialist and as Head of Orthopaedic & Dental Devices at an EU Notified Body.
I joined TÜV SÜD in June 2021 to lead the TÜV SÜD application to become a UK Approved Body for medical devices. With the UK exit from the EU there has become a need to provide UKCA certification services to our existing EU Notified Body medical device customers.
TÜV SÜD offered me the opportunity to use my knowledge and skills to set up a new UK Approved Body for medical devices. This was an exciting prospect and offered the chance to start something from scratch which was a welcome change after 13 years working for another established EU Notified Body for medical devices.
I work from my home office in Warwickshire, UK. I can often be found working with a cat asleep on my lap!
My main expertise is focused on the UK and European regulatory and certification requirements for medical devices. My professional background leans towards medical devices in the dental, orthopaedic and wound care areas and after 15 years working in Certification Bodies I have gained a much broader understanding and experience of a wide range of medical devices and in-vitro diagnostic devices.
My role currently involves leading a project to facilitate TÜV SÜD BABT Unlimited, as the TÜV SÜD UK Certification Body, to achieve MHRA designation as a UK Approved Body for the UK Medical Devices Regulations 2002 and UKAS accreditation to ISO 17021-1 for medical devices. This includes leading a small team of specialists to create a quality management system that meets the requirements for designation and accreditation and working closely with the wider BABT and MHS teams, in the UK and across the globe, to ensure alignment with existing certification processes and procedures. My role also includes authorising / appointing personnel, making certificate decisions, training staff, and liaising with designating / accrediting organisations for the UK Approved Body.
The part that I most enjoy about my role is that it allows me to meet, work with and learn from so many different people in a variety of roles and locations, both internal and external to TÜV SÜD.
I soon hope to be able to say that the highlight of my job so far is that we achieved designation as a UK Approved Body! Once we have achieved this designation, and our UKAS accreditation, we will start working closely with our existing clients to support them in transitioning to UKCA certification within the transition periods available so that they can continue to access the UK market. We have introduced an abridged assessment approach for existing clients which will allow them to leverage assessments performed under the EU Medical Devices Directives and Regulations in support of their UKCA assessment. In addition, and once available, we will be reviewing the text of the amendments that are planned to the UK Medical Devices Regulation and we will be updating our procedures and processes to fulfil any changes to the requirements.
It was exciting to see TÜV SÜD BABT and the Business Assurance team achieve ISO 17021-1 accreditation. I hope that the MHS team can continue the success and extend the scope of this accreditation to include medical devices in 2023.
In 2021 the MHRA consulted on plans to make changes to the regulatory framework for medical devices in the UK. These changes were influenced by the Cumberlege report titled “First Do No Harm”. They are expected to include reclassification of certain implantable devices, an extension of the scope of the regulation to capture some non-medical products that have similar risk profiles to medical devices and increase post-market surveillance requirements. The amended regulation is expected to come into force in 2023.
The biggest challenge is ensuring that we keep up with the changing regulatory environment for medical devices so that we can provide certification solutions that continue to focus on patient safety.
Having a largely home-based role has been a great perk for me as I have been able to spend less time commuting and more time with my family.
I have received extensive support from TUV SUD in my role for aspects such as resourcing and investment in IT infrastructure to support the UK Approved Body. What I have found most beneficial is the amazing support that I have received from individuals across the business in helping me to understand the TÜV SÜD organisation, collaborating, and providing time and effort to contribute to our designation process.
Knowledgeable, adaptable, supportive, honest, collaborative.
Embrace the change! The world of regulatory requirements for medical devices is changing at a fast rate, not least because of BREXIT and the UK plans to implement changes to the UK Medical Devices Regulations in the near future. But also because of the fast pace of change in the technology being employed in medical devices themselves such as Artificial Intelligence. Within a Certification Body role, we need to be able to interpret, act on and facilitate change in order to keep up with this environment.
(Dental Materials (2008), 24 (11), 1534-8)
Abdul S. Khan, Monisha J. Phillips, K. Elizabeth Tanner, Ferranti S. Wong.
(Adv. App. Ceram. (2005), 104, 261-267)
M. J. Phillips, P. Duncanson, K. Wilson, J. A. Darr, D. V. Griffiths & I. Rehman
(2003 J. Mater. Sci: Mat. Med (2003), 14, 875-882)
M. J. Phillips, J. A. Darr, Z. B. Luklinska, I. Rehman
A needleless syringe capable of accelerating particles into a target surface is provided. The syringe comprises a body having a lumen with a diaphragm located adjacent to a terminus thereof. Particles are delivered from an external surface of the diaphragm by means of the motive force provided by the impact of a shockwave imparted to the internal surface of the diaphragm. A method for delivering particles from the needleless syringe is also provided.
Bellhouse, Brian John; Bell, John; Millward, Huw Richard; Phillips, Monisha Jane; Nabulsi, Samih M
I represent TÜV SÜD at the Team Notified Body UK Approved Body working group.
Where does UK fit into your future regulatory strategy?
UKCA and UK Approved Body requirements and processes
If you'd like to find out more, please visit our healthcare and medical devices services web pages.
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