ESSEX, UK, Oct 16, 2025 – Europlaz has completed the recent FDA inspection, highlighting its willingness to supply medical devices into the US. Following a £4m investment in new equipments, the company reaffirmed its compliance with the regulatory requirements by FDA. The company plans to build on £1.5 million in U.S. sales and aims to double that figure within two years.
“A successful FDA inspection demonstrates that our systems, facility, and processes meet the highest standards,” explained Alastair Fry, regulatory affairs manager at Europlaz.
“It provides external validation that we operate with the same level of rigor expected of US-based manufacturers, giving existing and potential customers complete confidence in the quality and safety of the products we produce for them.”
He continued: “For medical devices sold in the US market, compliance to the FDA’s Code of Federal Regulations is not optional – it is a regulatory requirement. A successful inspection confirms that we can fully support customers in bringing their devices to the United States.”
The three-day inspection involved a review of Europlaz’s quality management system, manufacturing processes, documentation and production facility. Operating from its site in Southminster, near Chelmsford, Europlaz’s focus is on helping medical device and healthcare businesses commercialize new technology.
Alastair went on to add: “Compliance to the FDA’s Code of Federal Regulations ensures that quality is never compromised and that safety is built into every step of our production, whether its producing finished devices or components.”
The business has invested £4m into creating a facility capable of injection molding, assembly, product validation and access to cleanrooms (all ISO Class 7) for the manufacture of Class I and Class II medical devices.
Rory O’Keeffe, commercial director of Europlaz, concluded: “The successful inspection is recognition of the hard work and commitment of our team, so a massive thank you to them. And to the wider industry, we want to signal that we are ready to support the global innovation, compliance, and growth in healthcare and medical devices.”
About Europlaz
Europlaz Technologies Ltd., founded in 2000 and headquartered in Southminster, Essex, is a UK-based contract manufacturer specializing in ISO 13485-certified medical device production. The company serves the diagnostic, drug delivery, life sciences, and biomedical sectors, providing services such as rapid prototyping, injection molding, cleanroom assembly, validation, sterile packaging, and third-party logistics. Operating from its Southminster facility with over 110 people, Europlaz completed a £3.5M investment program to expand cleanroom capacity, support a 20% sales increase, and secure new contracts with medical device clients in the UK and internationally. Its production capabilities cover Class I to Class III devices. The financial filings of Europlaz for the fiscal year ending March 2024 report turnover of approx. £12M, or about $15M.