One of the UK’s fastest growing contract manufacturers for the healthcare sector is targeting new opportunities after appointing a new Regulatory Affairs Manager.
Europlaz, which recently announced completion of a £3.5m investment drive in new machinery and technology, has taken on Alastair Fry to head up its expanding team in this vitally important area.
The former designer engineer, who has more than twenty-four years’ experience in medical devices, has spent the last decade in regulatory affairs with a strong focus on both 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 own product range, including neonatal flow sensors.
The business also believes there is a £1m opportunity for Europlaz to help new UK innovators to navigate the costly and time expensive process of medical device compliance.
“I’ve had a lot of experience in the corporate sector, so when the opportunity came up to join a family-led business with a passion to make a difference, it was too good to turn down,” explained Alastair.
“My background is slightly different to most people in my position. 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.”
He continued: “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.
“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, which is ISO13485-certified and both MHRA and FDA registered, operates from its state-of-the-art production facility on The Maltings Industrial Estate in Southminster, near Chelmsford.
From here, 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 component parts.
It recently spent £750,000 on the installation of three additional all-electric injection moulding machines to cope with an increase in orders and this equipment complements robotic technology, Piovan material dryers, a new CMM machine and toolroom/cleanroom upgrades.
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.”
Alastair replaces David Bacon, who spent more than 17 years at Europlaz, firstly in the Quality department and then, in more recent years, as head of Regulatory Affairs. He will continue to use his extensive knowledge in a consultancy role for the business.
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