One of the goals we have for our medical device engineering projects is to ensure a high-quality medical device that is delivered at an exciting speed-to-market.
At Genesis, we have an ISO 13485 2003 Certified Quality System through which we develop medical devices.
In the beginning, we do engagement with the end user to define what are the user requirements for the product. Those requirements are converted into what we call Design Inputs. The Design Inputs then are converted into specifications, which we refer to as Design Outputs.
The product testing is completed according to protocols that we create, develop, and follow up on. While most of the testing is completed by one of our strategic vendor partners, we do a small amount internally as well.
Throughout our history, we have developed and delivered product through various manufacturing methods including:
- 3D Printing
- Injection Molding
- Raw Machining
- CNC Machining
- Swiss Lathe
- Surface Treatments
Completing the Process
Additional related operations that are involved in our drive the development process include:
- Product Validation
- Risk Assessment
- Supply Chain
- Manufacturing Access
- Quality Systems
- Payment Processing
Our Medical Device Engineering Experience
The individuals within Genesis represent over two hundred patents and innovations.
Our team has developed a large number of medical devices within the orthopedic market and outside of the orthopedic market.
Specifically, we represent a substantial percentage of devices that are sold in the shoulder arthroplasty space (around 40%).
That development experience does lead to inventions through a creative process that leads to filed intellectual property, filed patents, issued patents, etc.
In the end, this means that we have the ability, experience, and resources to begin with a blank sheet of paper that results in a successfully commercialized medical device.