Software Development For Medical Device

QPack ALM package for medical device provide you everything you need for your development lifecycle process.

- Requirements Management

- Test Management for Validation and Verification

- Tasks Management

- Defect Tracking

- Automatic generation of documents for the FDA (such as 510K)

- Support FDA Ruling 21 CFR part 11

- Risk Management

- Document Security

The tough challenges medical device manufacturers are facing in medical device software development include strict regulations compliance, especially with the requirements management, risk management and on to the medical device testing - validation and verification process. This challenge comes along with the constraints that any other development company is facing, such as faster time to market and budget. Medical device development manufacturers implement QPack application lifecycle management for Medical Device software development to tackle these challenges.

QPack application lifecycle management solution for medical device provides a single repository of data management for medical device development, providing professional ALM tools for all parties involved with the medical device software development, including market requirements (MRS), product requirements (PRS), risk management tool according to the FMEA standard and validation and verification.

QPack for medical device software development supports compliance with the FDA regulations, providing the customer with an end-to-end solution for the medical device development process.

Requirements Management


QPack Requirements management tool manages the complete requirements lifecycle, both high and low level, supported by strong reporting and traceability tools. You can easily manage traceability according to FDA regulations, build your documents in QPack and generate documents to the FDA with a click of a button.

 Tasks Management and Defect Tracking

QPack Collaborative task management allows your project team to implement better development along with the integrated Defect Tracking system.

QPack Defect tracking systems allow all project participants to easily submit, query, update, and report defects, where every single defect can be reported under specific requirements - guaranteeing Development Life Cycle requirements and bug tracking.

 Test Management for Validation and Verification


QPack Testing-Suite for test management provides all you need for your verification and validation processes. Operates over QPack ALM central repository, QPack Testing-Suite for validation and verification allows efficient test management, sharing of project data, tracking, and monitoring of test results, and generate Test plan document and Test Result document according to FDA 510K regulations.

With QPack Testing-Suite you can define testing requirements, plan and execute tests, report and track defects and trace requirements coverage.

FMEA Risk Management

Using QPack FMEA Risk Management helps you reducing the risk while developing your medical.

QPack integrates its FMEA based Risk Management tool in the application lifecycle management, allowing creating risk objects, manage risk properties such as RPN (= Risk Priority Numbers) , Mode of failure, cause of failure effect of failure and risk reduction.

Office Integration for FDA Documents Submission

Using QPack integration with MS-Word allows you to manage requirements both in QPack repository and in MS-Word documents. While generating the documents submitted to the FDA regulations, QPack automatically generates the formatted documents traceability matrix with embedded document security

QPack support for 21 CFR part 11 for software validation

QPack provides you with the ability to validate that your software systems meet with the FDA 21 CFR part 11 regulations. QPack built in tools allow you to manage software requirements specifications, manage verification and validation, along with integrated FMEA based risk management system, perform all levels of testing, and generate documents and reports accordingly.

Related links
Learn more about medical device software testing - verification and validation - VandV
Learn more about QPack ALM 2.0 solution for application lifecycle management