O.M.S. can create a team of talented industry leaders targeting the specific needs of each project to quickly develop unique Medical Devices, meet regulatory requirements, and satisfy all design and development demands resulting in a manufacturing ready device while keeping costs well under control.
O.M.S. can accomplish this feat by utilizing seasoned Medical Device professionals as consultants in key roles, allowing each individual to focus on the work s/he does best, while only paying for the exact time put into each individual project.
In addition, depending on the product, O.M.S. can assemble a full spectrum of engineering documentation that are 510(k), De Novo, PMA, CE (under new MDR) ready, including the following:
- Human Factors/Usability Testing
- Customer Requirements
- Hardware and Software Specifications
- Design Documents
- Risk Management
- True Traceability Documentation
- Verification and Validation Testing
- Creation of a Design History File (DHF)
- Preparation of a Device Master Record (DMR)
- Design Transfer Ready
QMS and Regulatory Development
Quality Management System Development & Review
We understand the classical development process and maintain our own Quality Manual System. Our Quality framework allows the flexibility for us to utilize a customer's existing system or design a new Quality system based on our own, constructed on customer or project needs. O.M.S. can help your company prepare for FDA 21 CFR 820, and/or ISO certification: ISO 13485:2003, 2016, MDSAP.
Regulatory Affairs System Development
O.M.S. can provide consulting expertise in National, International, CE Mark, ISO, 60601-1, and RoHs. In addition, we have experience with other international markets, such as Australia (TGA), Japan, Taiwan, Korea, Saudi Arabia, South America and a myriad of other countries. When O.M.S. designs a company’s Regulatory Affairs System, it is individualized towards the company’s specific circumstance. We create a structure that can be managed by the company, with its current staffing levels, with room to grow.
Another unique area that O.M.S. provides is the ability to simulate a project before the development even begins. This simulation of the end product provides accelerated communication between executive staff and development staff and results in decreased time spent on specification development. This simple tool also lends itself to use in sales or funding presentations, as well as systems training.
Create Manufacturing Tools
Automation and Testing tools can have a significant effect on manufacturing’s output speed, and also increase both accuracy and quality. These results in turn help companies improve their profit margins and dynamic flexibility to more quickly adjust to changing market demands. Having these types of equipment in-house can result in substantial improvements that launch companies into the next level of corporate growth.
O.M.S. has the knowledge and experience to create automation and testing equipment that will meet or exceed FDA and ISO regulation for medical device companies. Our long history of creating manufacturing tools enables us to provide services to varied companies with unique and differing needs using creative design and cutting-edge technology. O.M.S. prides itself in working closely with each company to identify its specific requirements and develop manufacturing tools to provide individualized solutions.