Medical Device Design
Innovation and smart user-centered design implementations are accelerating the use of technology to enhance and expand personal wellness, medical diagnostics, patient care and physician interactions. Data, the proliferation of use environments, advanced analytics and the falling cost of acquisition and storage is quickly changing what is possible. Telemedicine is becoming more widely embraced, wearable wellness products and point-of-care devices are enabling health care services to shift from a centralized to a distributed model, where the service comes to the patient.
Diatomic helps companies large and small navigate the engineering, regulatory and manufacturing challenges inherent in developing innovative medical devices and equipment. We can help with medical device design for digital health and wellness, diagnostics, monitoring, drug delivery, consumable, point-of-care, and surgical devices.
Our expertise includes creation and maintenance of development documentation to support medical device regulatory submissions, including risk management, quality planning, and verification. Our development process will take your new device through the following phases, to ensure ISO 13485 compliance:
Product Definition and Specifications
Risk Management
System Architecture
Detail Design
Prototyping and Testing
Verification and Validation
Transfer to Manufacturing