Europlaz recently announced completion of a £3.5m investment drive in new machinery and technology, and has now taken on Alastair Fry to head up its expanding team in this vitally important area.
Europlaz
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Alastair, the new Regulatory Affairs Manager, has over 24 years of experience in medical devices and has spent the last decade in regulatory affairs with a strong focus on the EU MDR (2017/745) and the UK MDR 2002 regulations.
His initial remit as Europlaz’s Person Responsible for Regulatory Compliance (PRRC) will be to look after devices where the company is classified as the legal manufacturer on behalf of clients, as well as ensuring conformity of its product range, including neonatal flow sensors.
The business also believes there is a £1m opportunity for Europlaz to help new UK innovators navigate the costly and time-consuming process of medical device compliance.
As Alastair explained: “ I trained as a design engineer and have also worked in product engineering prior to my transition to regulatory affairs - so I can understand both sides of the product journey. This really helps me build trust with the production teams and we can tailor design/manufacturing to ensure the required outcome for the client, but importantly that it conforms with all the technical, safety and regulatory requirements expected by the UK, the EU and internationally."
He continued: “Regulatory Affairs can be a very complex landscape, a landscape that can deter some innovators from moving into this space. I believe we can remove those barriers for them and deliver a one-stop solution to get their product to market. This could be a major growth area for us.”
Europlaz operates from its production facility on The Maltings Industrial Estate in Southminster, near Chelmsford. The company offers injection moulding, assembly, product validation and access to modern cleanrooms, all certified to ISO Class 7 for the manufacture of Class I, Class II and Class III medical devices or parts.
Most of its work is focused on helping medical device and healthcare businesses commercialise new technology, with recent success stories featuring a home dialysis machine, a patient-friendly and easy-to-use, breath-operated inhaler and a bio-artificial liver.
Katy O’Keeffe welcomed the appointment: “There has been an upturn in the number of companies asking us to become the legal manufacturer for them, mainly because it allows them to focus on what they do best. This is why Alastair’s appointment is so important to the business and gives us the opportunity to shape the Regulatory Affairs team so we can maximise this opportunity with existing clients, but also give new entries into the healthcare arena the chance to get their tech to market.”
