Quality and Regulatory Assurance Services

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.

FDA Submission Aspects

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.

FDA 510k development and submission (premarket notification)
FDA PMA development and submission (premarket approval)
Device Classification (FDA Classes I, II, and III, and Medical Device Directive Classes I, IIa, IIb, and III)
CE marking for construction of technical files

Medical Device Design Control Services

The FDA calls this “design control” while the ISO terminology for this is “Design and Development.” Either way, the processes refer to the same idea – documenting and recording the entire medical product development process.

Medical Device Design Input

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.

Medical Device Risk Analysis

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.

Medical Device Validation and Verification

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.

510k (Premarket Notification)

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.

PMA (Premarket Approval)

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.

Why Choose Outer Reef Technologies?

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.

Featured Services

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.

Program & Project Management
Systems Engineering
Mechanical Design
Electrical Design
Software Design
Regulatory Assurance
Quality Assurance

Product Examples

Robotics and Automation

Our main focus and core competency is developing robotic platforms from the ground up. We are proud partners with ABB and handle all of their medical applications.

Motor Controllers

No matter your motor controller needs, we have the solution. Our team can develop hardware and firmware for your sensored or sensorless BLDC motor.

Surgical Navigation/Motion Capture

We develop high accuracy and precision navigation systems for the medical and gaming industries. Our systems incorporate IMU, optics, and/or mechanical tracking options.

Surgical Suites

After working decades with the top surgeons, we have brought many Class III medical devices and suites to the industry from concept through clinical trials and 510k submission.

Imaging and Optics

Our team has extensive knowlege and experience developing and manufactiring optical devices ranging from LED fiber optics to rigid and flexible scopes.

High Precision Encoders

As nearly all of our products require the highest level of accuracy and precision, in a small form factor, we typically design our own encoder solution to meet the clients requirements.

Virtual and Augmented Reality

We have partnered with some of the top companies in the world to develop world class virtual and augmented reality devices. Our specialty is in sensor calibration, system integartion and verifcation.

Industrial Product and Packaging Design

Our design team utilizes SolidWorks to design and develop all of the products mechanical components. We utilize FEA and 3D printing to ensure our designs meet all requirements, prior to manufacturing.

Software and Application Development

These day there are apps integrated into nearly every product. We can support desktop, mobile and standalone apps, including apps which are required to integrate with the cloud and/or remote devices.