MEDICAL DEVICE ACCELERATOR

Tietronix Software, Inc.

1331 Gemini Ave, Suite 300, Houston, TX 77058

info tietronix.com htt ://www.tietronix.com

The Medical Device Accelerator (MDA) is processautomation software built specifically to deliver rapidFDA compliant medical device products. Just asTurboTax™ transforms the ordinary taxpayer into atax accountant, MDA takes you from innovation toimplementation faster, more compliant, and lessexpensively than any other development path. MDAprovides the ability to navigate and understand theFDA’s strict requirements for medical devicedevelopment. MDA provides adherence to designcontrols, user requirements capture, risk analysis,and company best practices. The use of MDAreduces development time, ensures regulatorycompliance, and enhances team collaboration. Thistranslates to shorter and less expensivedevelopment cycles, reduced costs, and quicker times to market.

Easy Adherence to Regulations:

MDA orchestrates well-defined workflow processesto achieve FDA compliance. This avoids theomission of critical steps or documentation thatresults in non-compliance.

Project Visibility:

MDA’s dashboard provides real-time project and

process status to authorized team members:

anytime, anywhere. The project manager candefine who has access to information within MDA.

Clearly Defined Roles:

The project manager defines roles, responsibilities,and assignments for all team members ensuringcollaboration and eliminating duplicated work.

Real-time Notifications:

MDA automatically notifies team membersassigned to specific work of changes to status,alerts, or new assignments. MDA providesimmediate notification in a “push” format. 

Process Automation:

MDA is a process-centric product using a workflowengine that automates any complex process. Thisworkflow engine, developed by Tietronix, executescomplex engineering processes in a flexiblefashion.

Document Management:

MDA provides full document configurationmanagement. MDA automates document reviewand approval (21 CFR part 11 complaint), createshighly flexible Change Control Boards, state-defines user document meta-data (e.g. draft, pilot,reviewed, final) and captures document changehistories.

Electronic DHF:

MDA electronically captures the Design History File(DHF) and provides tools to easily review pastproject information.

Repeatability:

MDA executes the same defined process and best-practices every time. New team members requireless training to do their job.