Portfolio

Research & Development

The objective of research and development (R&D) in a small or mid-sized business is to obtain new knowledge, applicable to the business’ needs, which can eventually result in new or improved products, processes, systems, or services that can increase your business’ sales and profits.

Maintaining in-house R&D services can be a costly affair for many enterprises, especially small and mid-sized businesses. Outsourcing R&D services can enable businesses to save costs on facilities or equipment used for research projects. Outsourcing of R&D processes also helps enterprises in gaining access to advanced technologies. Thus, outsourcing R&D services help enterprises in saving the cost of operations, which, in turn, will lead to an increase in demand for R&D outsourcing services.

Our team of expert help you with your R&D process or assist you in finding the right technology to acquire all with the aim to maximize your product’s market share. We make sure your design is optimized to capitalize on your competitors’ design weaknesses. Prospective, protocol-driven research speeds product development, decreases regulatory approval times, facilitates marketing efforts, and lowers product liability exposure.

Engineering & Prototyping

Our Experts have immense experience in concept development from ideation to design and development. Our engineering team design, prototype, and perform proof of concept testing for inventors, entrepreneurs, startups, and large companies alike. Our flexible development process gives you the opportunity to develop innovative products for different industries such as MedTech, Clean Energy and more. 

Using agile engineering processes and experts help us to create devices that function effectively and reliably. Our Product Development Services Include:

  • Mechanical Engineering 

  • Biomedical Engineering 

  • Electrical Engineering

  • Manufacturing Engineering 

  • Value Engineering

  • Risk Analysis

  • CAD Drawings – Manufacturing Prints

Regulatory Strategy & Testing

Our mission is to help with your FDA submission journey from developing the right strategy to eliminating the time consuming and expensive hassle of finding the right quality test and to develop the precise testing protocol which will minimize the risk of failure in your product development and FDA submission journey.

From early stage of development, it is essential to develop the right regulatory strategy to align the device impact performance, patient characteristics, operator technique refinements, safety and human factors with FDA requirements. Our experts give you a sound understanding of the premarket submission process and will provide guidance and strategy beginning with early stage FDA strategy and feasibility study to the pre-submission phase and following through to assuring the best possible decision outcomes. Our experts fully understand the latest FDA regulatory requirements and have a wealth of experience in liaising effectively with FDA staff throughout the process.

Another critical steps in mitigating the risk of failure and preventing spending a significant amount of time and money at early stages of development are early proof of concept testing, engineering design verification and performance testing. Our FDA experts will also help you with the right strategy and our testing services alongside developing suitable performance test method and protocols accompanied by a complete analysis report would prevent receiving FDA refuse-to-accept (RTA letters), or worse yet – Not Substantially Equivalent (NSE) letters which cause delay or failure in the FDA submission process.

Our Testing services:

  • XRF, XRD, SEM and TEM

  • Real time particle size distribution  

  • Physical characteristic and durability of materials

  • Surface and Physicochemical characterization

  • Thermal measurements and analysis (Thermal Diffusivity, Thermal imaging,…)

  • Vibration analysis for sensors and electronics

  • Soft tissue biomechanics characterization

  • Biopolymer analysis and testing

  • DSC and TGA

  • Electromagnetic tests (EMI, EMC)