Medical Device Software Development Services

Medical Device Services Banner - Medical Device Software Development

Medical Device Services

Tietronix provides a full spectrum of medical device development services to help bring your project from concept to market. We offer custom medical device software development, a Quality Management System (QMS) software application that complies with FDA regulations and ISO 13485 standards, and visualization services.

Tietronix is in a unique position to help develop your medical device software, efficiently manage your product development projects while ensuring FDA QMS standards compliance, and communicate your design and operations visually to internal and external stakeholders.

Medical Device Software Development

Full lifecycle development

Detailed requirements and design capture

Independent verification and validation

FDA and ISO compliant development processes

24/7 project status and access

Quality Management System (QMS)

Electronic document management

Electronic signature

Corrective and preventative action (CAPA)

Design control process

Design history file (DHF)

Defect tracking

Quality control

Risk analysis

Audit trails & reports

Customizable processes

Visualization Services

Visualization of design concepts from prototyping to final rendering

Effective method of communication to investors & stakeholders

Animation of medical procedures

Simulations of device operations