Design & Engineering
Outer Reef Technologies
These steps include the following:
Systems engineering plays a huge role in medical device development and includes various steps, like documenting product requirements and design, identifying risks, and finding solutions to any problems that arise during the development process. Simply put, systems engineering tackles the development process as a whole and encompasses operations, performance, support, and testing. Taking a systems-engineering approach to medical device development is, therefore, a holistic approach that makes the entire development process more efficient and risk-free.
The medical engineering consultants at Outer Reef Technologies are highly trained professionals with years of expertise in medical device development and manufacturing. Our medical device experts in mechanical engineering, electrical engineering, systems engineering, design engineering, and more ensure that your experience with us is not only streamlined but also results in the best possible product.
Our medical device design engineering services ensure the conception of well-thought-out and tested designs that hold up when the product is produced. Because the final product’s functionality depends on the design, our team of in-house experts works around the clock to create unique designs that fit our clients’ exact needs. Whether you require individual components, surgical equipment, or entire devices, the team at Outer Reef Technologies can be of service.
Specification development takes place after the research and discovery phase and consists of formulating specifications for the medical device being designed. These specifications include electrical and mechanical to software requirements and cover areas like functionality and safety. This early stage is especially important since caution here can help avoid costly modifications later. Hiring medical device experts experienced in medical product development is integral to ensuring the success of the project. Failing to do so can result in loss of both time and money.
Because developing embedded systems is such a complicated and time-consuming process, it necessitates hiring Medical Engineering Consultants who are not only competent but also experienced in all aspects of the project. This includes design, simulation, verification, and validation. The process is also risky, which makes this even more important – with Outer Reef Technologies, you will not have to worry. Our integrated embedded systems development solutions are established and can be relied on.
Mechanical and electromechanical systems are a large part of medical device manufacturing. Complicated electromechanical systems and assemblies are used in all sorts of medical devices, including those used in treatment centers, clinics, and hospitals. Extensive experience is required for proper development and the various steps within, including prototyping, assembling, and testing the devices. To expertise, the process also requires an influx of cash.
Outer Reef Technologies not only provides you with the best minds in the industry but also aims to do so at a reasonable price. Additionally, because we’re ISO 13485 compliant, you’ll never have to worry about quality control.
Fault Tree Analysis (FTA) uses a top-down perspective when evaluating medical devices. It uses “and” and “or” logic gates to evaluate safety and can detect sequences that can result in system hazards. Our medical device experts use FTA to identify and rectify any design weaknesses.
Failure Mode Effects Analysis (FMEA) uses a bottom-up perspective to evaluate medical devices and is extremely thorough since it takes every element into consideration. In addition to helping detect and eliminate product failure modes, it also reduces costs and improves product reliability.
Outer Reef Technologies complies with ISO standards, and uses FTA and FMEA to identify hazards such mechanical hazards, electric shocks, and chemical poisoning and provide risk mitigation strategies.
Medical device design and manufacturing is no simple task – that’s why you need medical device experts and the best team possible to do the job well and make getting approvals from the relevant authorities as simple as possible. Outer Reef Technologies has years of experience in medical product development and has dealt with everything from surgical equipment to robotics. Our CEO and founder, Jonathan Azevedo, has been in the industry since 2009 and helped develop the first orthopedic robotic platform.
If you’re interested in working with us, learn more about us here or simply contact us here – we look forward to hearing from you and starting the medical product development journey together.
Product development services include but are not limited to; medical device development, robotics, electronics, firmware, software, mechanical design. Our team can help from initial concept through product launch and anywhere in-between.
Our team excels in understanding regulatory requirements for developing a thorough and cost effective plan, to meet your specific needs. We can assist in developing a quality management system for your company, guiding products through regulatory testing, and formal submissions such as FDA/EU/CE.
As we have many years of experience in new product development and prototypes we have transitioned over the years into also supporting our clients from production equivalent builds used for verification and validation to full production line support of complex electro-mechanical and optical assemblies.
Thank you for you interest and we look forward to speaking with you! Call us directly to speak with one of our engineers or feel free to email us and we will contact you within 24 hrs to discuss your project needs.