ISO 13485 is a vital certification for any business operating within the medical industry.
To prove yourself to be a qualified organisation, capable of meeting and surpassing the requirements for regulatory purposes, ISO 13485:2016 certification must be granted.
Why Are We ISO 13485:2016 Certified?
At Oracle Precision, we’re passionate about demonstrating our commitment to manufacturing medical devices & instrumentation, that meet customer and regulatory requirements. Our services encompass multiple stages of the product life cycle, including development, production and storage, so we understand that out our customers rely on our ability to do our job efficiently.
What Is ISO 13485:2016?
Being one of the most heavily regulated industries, medical devise & instrumentation manufacturing is fraught with processes and requirements. These are to ensure that all devices that are manufactured in the industry are consistent, in terms of design, production and quality controls. Of course, this certification has been created to ensure that all devices are safe for their intended medical purpose.
The History Of ISO 13485
ISO 13485 was first created back in 1996, with the intention of becoming a Quality Management Standard for medical device companies. However, two versions of the Standard were published:· ISO 13485, for manufacturers · ISO 13488, for suppliers This detailed subtle differences in service requirements, however, in 2003, the two Standards were combined and this ISO certification is universally applied to manufacturers and contractors, alike. There are many benefits to becoming ISO 13485 certified and we, at Oracle Precision, benefit from these, every day: · Achieving competitive advantage and company credibility · Increased customer satisfaction · Continuous improvement of processes · Improved employee knowledge
Our Medical Device Manufacturing Services
As a leading UK medical device manufacturer and CNC machining expert, Oracle Precision is the ideal partner for your subcontract medical device manufacturing requirements.
We are an ISO 13485 compliant medical device manufacturing company with extensive experience working within industries where quality and safety are truly critical. Our team of precision engineers are therefore well versed in stringent compliance requirements, the necessity for adherence to close tolerance work, and a strong understanding of end user requirements for surgeons and patients alike.
Medical Device Design and Development
As a core part of our medical manufacturing services, we can aid with the initial design process for efficient manufacturing. This ensures perfect manufacturability and that all components are fully compliant with both design intent and associated regulatory requirements. Whether you’re looking to create metal, plastic, or composite devices. The Oracle team can also source the right material suppliers and secondary processes with our supply chain procurement and management services.
Medical Device Prototyping
From design to manufacture, we can also rapidly produce prototype medical devices in various volumes for testing, demonstration, and trials. As rapid prototyping experts, our team can produce one-off or batch medical device prototypes with a superior turnaround time.
Medical Device Manufacturing
With expertise and experience in the machining of a variety of exotic and less exotic materials alike, Oracle Precision is fantastically placed for the manufacture and supply of medical devices, associated instrumentation and a range of ancillary components. Our manufacturing services include one-off and batch medical machining.
Reconstructive Medical Device Manufacturing
Hip and knee implants are both common reconstructive medical devices. Prosthetic joints can greatly improve mobility and quality of life when they are manufactured using the right materials and with pinpoint accuracy in size and structure for the individual patient. With CNC machining, it’s possible to produce artificial joints that perfectly fit the patient, giving improved outcomes with joints that last and are biocompatible.
Medical and Surgical Instrument Manufacture
It is also crucial for the instruments medical and surgical staff use to be fully safe and reliable; to this end, the machining of medical and surgical instruments is another crucial area of medical engineering. Whether you require a small batch of specialist instrumentation or a larger number of instruments, Oracle Precision has the technology and capabilities for your requirements.
Dental Instrument Manufacturing
Dentistry is another area where quality-critical devices and instruments are crucial to excellent patient outcomes. Oracle Precision can create high-performance dental instruments for the examination and manipulation of teeth and mouth.
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