There are multiple factors that make medical devices a highly complex strand of manufacturing, including stringent government regulation and standards (particular to each territory), technology and materials selection. It is often challenging to ensure a fully compliant outcome that also meets precise commercial manufacture aims and customer needs.
At Romar Engineering, we’ve provided expert medical device manufacturing for decades. With leading expertise in medical-grade silicone, molding, clean room manufacturing and advanced manufacturing, we can streamline complexities and provide a faster route to market – with safety, compliance and efficiency guaranteed.
Here are four key ways that Romar overcomes the complex manufacture of medical devices to provide expert, robust and scalable manufacturing solutions.
Globally compliant manufacturing
Medical device manufacturing is highly regulated to ensure consistently high health and safety standards for consumers. Manufacturers must address stringent regulatory guidelines at every stage of manufacture for every type of medical device, from wound dressings to breathing apparatus and medical implants.
At Romar, we have robust quality management systems to ensure our continued compliance with statutory and regulatory requirements including international standard ISO 13485 for the manufacture of medical devices.
Our industry-leading team of materials, mechanical, bio-medical and process engineers can make tailored recommendations for manufacturing medical devices that meet Australian and global standards.
Materials selection expertise
Effective medical device manufacturing also requires a thorough knowledge of materials to ensure material choice meets project aims such as environmental conditions, usage, production run and budget.
Romar’s broad manufacturing capability includes silicone and elastomers. We employ medical-grade silicone in developing medical devices, suitable for either time-restricted or unlimited human implantation.
Our broad portfolio of silicone elastomers for application in the healthcare industry has been tested against UPVI and ISO 10993 biocompatibility standards.
Our expert team can formulate rubber to suit any specific application and modify factors including colour, degrees of hardness or softness, coefficient of friction or insulation and semiconducting properties. Our expertise is central to considered and tailored medical device material selection.
Advanced technology
Over the last decade, medical devices have incorporated heightened levels of innovation, driven by new technologies including advanced and additive manufacturing.
The medical industry is starting to embrace advanced manufacturing techniques and processes to enable fast, cost-effective and high performance medical manufacturing.
Romar is leading the way with expansive capability across medical grade silicone, medical device manufacturing, elastomers and additive manufacturing, we provide tailored and holistic manufacturing solutions at the intersection of traditional and transformative technologies.
Our facilities and equipment include a Class 8 clean room, a Leitz CMM for precise measurement of physical geometrical properties and our Lasertec 65, a 3D printer with enhanced hybrid capability unique to Australia.
Turnkey manufacturing solutions
The complexity of medical device manufacturing can be exacerbated when dealing with multiple partners and long supply chains.
Romar simplifies this with full capacity in turnkey manufacturing spanning analysis, design for manufacture, materials selection and commercial manufacture.
As a turnkey manufacturer, we provide a single point of contact for quoting, invoicing, scheduling and logistics, we minimize potential project delays due to miscommunication between multiple vendors, and we shorten the supply chain, enabling faster and more cost-effective production.
Romar is a leader in Australian manufacturing and respected globally. If you have a medical device project needing complete, compliant and innovative manufacturing solutions, please contact us.
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