Life Cycle Acceleration, Risk Mitigation and Regulatory Observance

The role of software is a significant area of complexity and growth that has occurred within the industry. Today software impacts the industry in multiple ways. It can function as an integral component of a medical device, a standalone device, or even a mobile device application. Because of the usability expansion and exploding growth in the market, many software products are becoming available that exhume significant risks. Our proprietary model helps mitigate risk to the patient by ensuring systematic processes that achieves compliance  and quality in changing regulatory environment.

Advancement of Technology Increases Complexity and Risk

There are some software products hitting the market that pose significant risk. Developers still lack the guidelines, policies, standards and processes that ensure they bring safe products to patients and ensure quality patient outcomes. Some of the reasons for this have been lack of standards, as well as a lack of regulatory clarity. It can even be unclear if a software product qualifies as a medical device. Because of the accelerated market expansion, regulatory authorities are working to provide guidelines for the new frontier of AI (artificial intelligence). Technology is moving so quickly, it is challenging to quickly formulate regulations for this rapidly evolving landscape.

When is Software Considered a Medical Device?

When do software products quality as medical devices? Complexity and integration have created confusion on whether the software is a standalone product or not. If the software is considered a standalone product, it must meet all of the regulatory requirements of a conventional device. Regulators across the globe have begun to address some of the challenges that arise when software and medical devices merge. Standards and regulations have begun emerging such as the MDD 93/42/EEC (Annex IX), Guidance MEDDEV 2.1.5, European Directive 80/181/EEC, IEC 62304 and IEC 82304. Other regulatory considerations include:

  • 21CFR820, Quality Systems for Medical Devices
  • 21CFR11, Electronic Records and Signatures
  • FDA General Principles of Software Validation
  • Off the Shelf Software for use in Medical Devices
  • Guidance on Pre-Market Submissions for Software Contained in Medical Devices
  • Guidance on Computerized Systems Used in Clinical Trials
  • Cyber security for Networked Medical Devices Containing Off-The-Shelf Software
  • ISO 13485 – Medical Devices – Quality Management System
  • IEC 62304 – Medical Device Software, Software Life Cycle Processes

Medical Device Software Life Cycle

Our detailed analysis of the device software life cycle allows us to build processes and procedures that mitigate risk, accelerate the speed to market, and ensure quality patient outcomes. It also avoids the cost of multi-million dollar recalls that are becoming more prevalent in the market. Our proprietary models include the analysis from concept, requirements, design and development, implementation and verification, validation, integration, testing, resolution, configuration, quality assurance, risk management, release, customer feedback, software maintenance and post-release design changes.

Our Proprietary Model Showcases Flexibility & Mitigates Risk

Our team of professionals integrates with various facets of methodologies including the Agile, V Model, Iterative or Waterfall concept. Our risk mitigation solutions architect a flow of checks and balances that streamline policies and procedures, software design reviews, design verification and validation.

Our Deliverables & Methodologies Produce Quality Patient Outcomes

  • Software Development SOP
  • Development Plan
  • Software Risk Management
  • Requirements
  • Software Architecture
  • Software Detail Design
  • Code Review
  • Unit Testing
  • Integration Testing
  • System Training Software Release & Maintenance
  • Software Change Control