Scalable medical device manufacturing requires advanced manufacturing facilities, leading material experts and a proven 360-degree solution process.
Romar has been at the pointy end of delivering manufacturing solutions for some of the most innovative medical devices in circulation today.
Successful medical device manufacturing is built by a biomedical engineering team working with the best technology and supported by material scientists who have a thorough understanding of the characteristics of silicone and are authorities on material selection, with a comprehensive knowledge of the FDA case studies approval process.
Scalability is the key
The ability of the manufacturing process to handle increasing demand while maintaining efficiency and quality to meet the rising needs of the healthcare industry, accelerate market entry, and ensure patient access to life-saving technologies is a key pillar of Romar’s scalability expertise.
“Our level of expertise in the medical industry puts us in a unique position, and there are very few companies that offer the complete and scalable service we offer.
Our experienced team of over 20 engineers, including biomedical engineers, ensure we meet all the regulatory requirements to obtain TGA and FDA approval. You come in with the idea and we’ll apply the science.” ~ Alan Lipman, CEO
Successful medical devices are a high-demand product, and the healthcare sector needs a reliable and consistent supply with the highest quality control standards. Romar’s class 8 clean room facility is the largest in Australia and the Asia Pacific region and is at a world-class standard.
Design validation process
Design validation is a crucial stage in medical device manufacturing, ensuring that the product meets its intended use and user requirements. This process involves testing the device’s design under real-world conditions to confirm its safety, effectiveness and compliance with regulatory standards. Design validation activities encompass various testing methods, including usability studies, functional testing and performance evaluations.
By conducting rigorous design validation, we identify and rectify potential issues early in the development cycle, enhancing product reliability and minimising risks to patients and healthcare providers.
A 360-degree scalable solution
From design and material selection to scalable manufacturing and shipping, Romar is a 360-degree scalable solution for medical device manufacturing. As a team of process experts, we take the initial medical device idea and design a process that moulds the device and does the assembly, validation, approval and packaging.
Our team develops the Device Master Record detailing the manufacturing. Work instructions, bill of materials, quality control and assurance plan and specifications, including packaging and labelling are part of the documentation. The Design History File and Device Master Record ensure the medical device complies with the regulatory requirements.
It pays to work with the best. Our team members are highly qualified and experienced, with the attention to detail required to ensure success. When you’re ready to collaborate with the best biomedical engineers and experts with access to world-class facilities in Australia and Southeast Asia, contact Romar for a complete and scalable medical device solution.
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