Quality and Regulatory Assurance Services
Outer Reef Technologies
Process development is used to create, put into place, or improve a manufacturing process. Medical product development is complicated – it involves assembly, testing, packaging, and more. In addition to this, all processes have to be compliant with the relevant guidelines. All of this should be tested before manufacturing at scale to optimize production and minimize cost. Outer Reef Technologies is here to help you with that – whether it’s FDA, EU, or CE approval, we cover it all.
Before a product goes into the market, your business must obtain FDA approval and/or CE Marking – because this is a long and complicated process, we provide comprehensive submission services. The following are the four main areas we cover.
This is the basis of the medical device and its design. Design inputs are requirements, i.e., they define the needs of the user and consist of product specifications, intended use, and claims.
This stage determines the safety and usability of the medical device. As the design evolves, it can affect risk and usability – these are tested repeatedly to ensure safety.
This step consists of proving the efficacy of the device and aims to prove the claims made by the manufacturer. The verification process confirms that all requirements have been met while the validation process determines whether the device lives up to its claim.
Premarket notification requires substantial equivalence, i.e., evidence of the device being as effective and as safe as the one before it. It should have the same purpose as the previous device and the same technological characteristics. If the technological characteristics are different, there should be no safety or effectiveness concerns. Additionally, it should be demonstrated that the device is just as safe and effective as the one before it. The premarket notification can be divided into three categories – traditional, special, and abbreviated. This process results in FDA clearance.
Premarket approval is required for high-risk devices (Class III devices) that may cause injury or illness, or those that aren’t equivalent to the processes for Classes I and II approval. This is a more complicated and involved process and includes submitting clinical data that proves the claims made by the device to the FDA. This results in FDA approval.
Not only do we understand regulatory requirements, but we also know how to develop a plan that is both, thorough and cost-effective. Additionally, we stick with you through the entire process, from developing a quality management and regulatory system to guiding and testing all the way to submissions to the FDA/CE/EU.
In addition to our expertise in medical product development, custom motor controllers, and 3D optical tracking, we are also partnered with ABB Robotics. Our in-house experts have invaluable experience in medical product development and manufacturing – because we’re associated with manufacturing, we’re well aware of all quality assurance systems and guidelines and are completely ISO 13485 compliant.
Additionally, our CEO and founder, Jonathan Azevedo has been in the medical device industry since 2009 and even helped develop the first orthopedic robotic platform. Our partnership with ABB Robotics and our continued innovation in custom motor controllers and 3D optical tracking makes us one of the best medical product development companies out there.
Simply put, we have the knowledge and expertise, and we make sure to put your company’s needs above all else.
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.