Medical Device

Medical Device Design and Services

Recent advances in technology have opened the door to many exciting new product opportunities for medical device firms. But competitive pressures and strict regulatory requirements make it tougher than ever to bring a new product to market. In addition, Medicare and insurance cutbacks on patient reimbursement are putting pressure on margins.

Deaton Engineering applies a risk-based approach to medical device manufacturing. This technique can deliver substantial improvements in productivity while maintaining the highest assurance of product and human safety. We deliver cost-effective, FDA-compliant solutions by assisting you in developing a plan to meet your goals.

We employ a Total Quality Improvement methodology for design, validation, and manufacturing. We partner with you to develop and deliver innovative engineering solutions to support your project initiatives, whether it's a mechanical design, a production scale-up, a major automation project, or a plant expansion.

Medical Device Industry Services

Medical Device Design
Deaton Engineering is experienced with the FDA's requirements for medical devices. We incorporate good documentation practices and validation strategies into our designs. We consider the impact of the design on manufacturing techniques, cost control, cleaning, and sterilization procedures. Our engineering staff can produce your medical device prototypes and provide documentation for 510K submittals, and UL and CE certification.

Validation Services
Deaton Engineering manages the validation process by developing a strategy that includes requirements, risks, and test procedures to ensure compliance with good manufacturing practices. Deaton Engineering can develop Installation, Operation, and Performance Qualification protocols for any type of manufacturing process, facility or equipment.

Manufacturing Automation and Equipment Design
Deaton Engineering designs fully automated manufacturing systems that incorporate industrial robots, vision systems, and QC testing. We specialize in building turnkey process and equipment solutions that are reliable, cost-effective, and GMP compliant.

Process and Facility Engineering
Deaton Engineering provides expert engineering services to support FDA-approved facilities. Our services range from concept through start-up and validation.

Design