Medical Devices / ISO 13485 / 21 CFR Part 11

ISO 13485 Software – No User License Fee

The Medical Device industry faces multiple and increasingly complex challenges, these challenges may be due to:
  • Product proliferation or geographical expansion
  • Numerous changes in ownership/responsibility in the supply chain
  • Increasing regulatory requirements such as 21 CFR Part 11
  • Difficulty in maintaining oversightof the supply chain
  • Manual processes, poorly integrated IT systems
  • Cost control

Momentum QMS provides the tools and techniques necessary to address such challenges by helping organisations maintain an effective ISO 13485 compliant Quality Management System. Moreover, the system can be validated and implemented according to regulatory requirements such as 21 CFR Part 11

Make more informed decisions and achieve your goal of achieving and maintaining ISO 13485 compliance with Momentum QMS.

ISO 13485: Section Requirement Momentum QMS

4: General Requirements

Understanding the context and needs of the Organisation. Determine the scope and continually improving the QMS. Maintaining records and documentation related to the design, use and manufacture of devices.

Provides industry best practices and can be tuned to meet your organisation’s unique requirements/processes. Out of the box processes for managing and distributing documents and records.

Key Modules/Takeaways: Flexibility and Adaptability, Document Control


5: Management Responsibility


Customer Focus

Management Review

Quality is not one person’s responsibility, leadership needs to be accountable and promote the principles of Quality Management.

Risk-based thinking – Quality Objects and Planning

Decentralization of a centralized system. Momentum QMS is a centralized software however the roles, responsibilities and accountability is de-centralized. This allows leadership to not only communicate, enforce and promote Quality principles but at the same time enable teams to work collaboratively to solve problems. Out of the box modules

Key Modules/Takeaways: Centralized Software, Customer Feedback, Meetings Management, Objectives Management


6: Resource Management

Organization should demonstrate they have control over resources, including Human Resources, infrastructure and working environment.

Momentum QMS enables you to manage data related to customers, suppliers, equipment, assets etc. Moreover employee data including the management of training (offline or online) can be performed directly within the system.

The system also comes with Health and Safety modules that enable you to manage the requirements related to the working environment.

Key Modules/Takeaways: Master Data, Employee Training and Incident Management


7: Product Realization

Requirements related to the planning, review, design, purchasing and creation of the product or service.

Momentum QMS comes with an array of integrated modules that enable organisations to manage the lifecycle of a product or service.

Utilities such as Risk Assessments can be integrated at desired stages of the lifecycle to prioritize and add/justify controls

Key Modules/Takeaways:
Document Control, Product Specification Management, Risk Management, Integrated Modules


8: Measurement, Analysis and Improvement

Monitoring of the QMS, assessing Customer Satisfaction, Internal Audits, managing Non Conformances and implementing corrective/preventive actions.

Using the Customer Feedback module customer relationship is enhanced and any improvements are carried out in a systemic manner.

Audits can be developed and captured directly in the system with actions and investigations assigned to appropriate people so that there is accountability within the team.

With standard modules for tracking Issues, Non-Conformances and Corrective actions you can be assured that all manner of issues are properly reported, assessed, investigated and controlled.

Reporting, Trending and Alerts form a key component of the continuous monitoring, measurement and improvement of the system.

Meetings management allow the capture of management reviews and any actions are tracked in the system for future followup meetings.

Key Modules/Takeaways: Customer Feedback, Audits, Meetings and Analytics



Training and Document Control form the basis of any Quality System. Momentum’s Training Management System records employee training and provides tracking of pending or upcoming training is critical to maintaining compliance.

The Training module works independently or integrates with Document Control module to keep a track of the various competencies that are directly linked with an employee. Competencies can be assessed directly within the system or recorded as part of training courses that are held on site.


  • Quickly import your current checklists into Momentum QMS.
  • Capture custom responses, record photographs, electronic signatures and more.
  • Raise findings and assign actions to team members or external users.
  • Schedule audits and ensure that previous audit findings are monitored and closed off.


Import your current risk matrix and risk register and hit the ground running with your risk framework. Risks   may originate from Product Issues, Customer Complaints, Food Safety/HACCP, Hazards, Incidents etc.

Assess risks based on a risk matrix with any number of dimensions (Severity, Likelihood, Detectability etc). Risk matrices are completely configurable whereby users can also be supplied with guidance information so that they make informed decisions.

Implementation of controls can be delegated to team members and monitored until they are completed successfully. Alerts and monitors can be created to monitor and re-evaluate risks on a regular basis ensuring that no critical issues fall through the cracks.


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