Our Product Development Process:
- Create medical device product concept
- Design medical devices with 3D software
- Prototype medical devices using rapid prototyping technologies
- Validate medical device design via testing
The success of a medical device project is dependent on careful consideration of several intersecting factors: technological, medical, commercial, and legal. We employ a step-by-step approach to help us achieve a methodical medical device design and product development strategy. We ensure that these procedures are followed during the development process for medical devices by focusing on clear problem identification and risk reduction for a variety of potential answers. At later stages, the range of medical device design alternatives narrows considerably and converges on a final product that has been thoroughly tested to meet the customer’s expectations and is ready for sale.
Our Product Development Process:
SRC medical has medical device design professionals with expertise in all medical device skills including but not limited to:
Medical Devices Engineering: Our custom engineering team is experienced in medical device design engineering, verification & validation, regulatory submission processes, production preparation, and medical device quality systems. We have experience with a variety of product design software including Solid Works, and AutoCAD as well as medical devices rapid prototyping techniques such as CNC machining and 3D printing.
Medical Device Consultants: We work with medical device consultants to help you with the medical devices design process. At SRC Medical we understand that medical device consulting can become a specialized industry unto itself. Even medical device consulting professionals are not familiar with all medical devices design issues. We work with consultants who have experience in medical device product development, medical sales, and marketing, medical regulatory affairs, or medical production management.
After our initial research is completed, we may begin developing concepts. With a proven track record of success in product development, we pride ourselves on our ability to develop an entire medical device from nothing more than an idea or sketch. This is one of the most important phases in the project, and it sets the stage for future stages by combining creative thinking with practical problem-solving. We provide a comprehensive design package or focus on the development of just one component of a medical device or drug delivery product, depending on your needs. We use our cross-functional teams to come up with ideas, taking advantage of SRC’s vast engineering resources. Our clients keep all rights to any novel intellectual property they create as a result of this approach.
Our in-house equipment and skills are used to produce fast prototypes, such as 3D printing, CNC and injection mold tooling. Prototypes that resemble and feel like finished goods can be created to assist designers in advancing design while determining the form, fit, and function of a product. Having the capacity to create prototypes and conduct design changes in-house helps to reduce costs as well as speed up and simplify the development process. Product evolution from the prototype stage to manufacturable assembly happens through multiple iterations of medical device design services, refinement, and evaluation. Our project team will have the specs and initial supporting test data for a working product at the conclusion of this phase.
Our design team offers cutting-edge medical device and packaging design services. Our Design Control processes translate early ideas into engineering design specifications. Packaging development is frequently handled in parallel with device and component creation, making it a standard part of our process. Our medical device package designs are geared towards ease of use to the medical profession while maintaining compliance with government regulations. Attention to detail is critical in medical packaging design. Packages must be designed for efficient assembly to reduce manufacturing costs, while also providing maximum product quality and safety during storage and delivery; each aspect of medical package design is equally important.
The medical devices must be tested to ensure they are safe and effective. We provide medical device design services for medical testing, size requirements, clinical trials, etc. Our medical devices can also be designed using materials that are tested in accordance with ISO 10993 standards. Generally speaking, medical device validation involves clinical tests of the medical device to demonstrate that it is safe and effective for medical use. SRC’s medical device design services help you keep your product quality high. Our medical device design services provide complete medical devices and medical products that meet or exceed customer expectations.
Registered with the FDA as a Contract Manufacturer
Compliant to 21 CFR Part 820 Quality System Regulation
Certified to EN ISO 13485:2016 Quality System
CE certified for metrology—manufacturing of reusable, graduated, vaginal cream applicators.
Product inspections based on ANSI/ASQC Z1.4:2003 sampling
Support to 21 CFR Part 210/211 with our Pharmaceutical customers
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