Medical Device Software Development

Medical Software Life Cycle Development – ISO 13485 Registered

Tietronix is an ISO 13485 registered company that adheres to FDA medical device regulations for custom medical software development.  Tietronix utilizes our QMS product suite to manage in-house software development projects.  Our strength lies in our highly repeatable and disciplined approach to software development.

Visibility and Transparency

MDA (Medical Device Accelerator) is our web-based QMS product suite that we use during the software development process.  MDA provides the customer with real-time visibility into the process and project status.  Documents produced during development are available for viewing instantly and can be electronically reviewed and approved.

Detailed Requirements and Design Capture

It is essential to define product requirements in detail, so that each requirement is uniquely descriptive and testable.  A good requirements document is the cornerstone of any project and Tietronix puts considerable energy and focus into capturing and defining each and every requirement.

Independent Testing - Verification and Validation

Formal Independent Verification and Validation (IV&V) testing is performed by an independent V&V team to ensure the highest quality of product software testing possible.

FDA and ISO Compliant Software Development Processes for

FDA CFR 820.30, Design Controls
ISO 13485, Medical Device Quality Management System
ISO 14971, Medical Devices – Application of Risk Management to Medical Devices
IEC 62304, Harmonized Standard for Medical Device Software
CMMI Level II (working towards Level III) Capability Maturity Model Integration