"If not properly secured, medical devices, such as bedside telemetry or implantable devices like pacemakers and insulin pumps, can introduce malware to the network or, in extreme cases, be hacked, and could harm the individual whose medical device was compromised,"- Lynne A. Dunbrack, Research Vice President, IDC Health Insights

The medical device industry facing a rapid growth in the current dynamically expanding global healthcare market. Due to the critical role they play in our lives, medical devices need to be verified and validated for quality and regulatory compliance requirements of different nations in context. In order to ensure high quality, safety and to avoid product recalls related unnecessary costs, medical device organizations inevitably needs reliable and strategic technology and QA partners.

Medical Device Testing

Challenges
  • Need for knowledge of regulatory compliances such as American FDA, European CE, etc.
  • Knowledge of other industry standard such as IEC62304:2006, and more
  • Availability of testers with relevant domain and industry knowledge & certifications
  • Availability of infrastructure setup and ability to leverage perform QA using Service virtualization
  • Device agnostic test automation framework that can support automation on diverse medical devices
The Solution

Cigniti's rich expertise in QA/testing of medical devices helped its clients reduce production costs, accelerate time to market, comply with regulations, and improve quality of services to patients while adopting latest technologies and best practices.

Leveraging 15+ years of vast experience in QA/testing coupled with deep-domain knowledge, Cigniti offers end-to-end quality assurance and regulatory compliance validation services to medical device organizations. Cigniti's rich pool of top-notch professionals with multi-domain skill sets helps our clients accomplish their quality, validate their readiness for regulatory and compliance requirements and accelerate business outcome. Cigniti QA/testing practice specific to medical devices conforms to FDA Quality System Regulations (QSR) and help its clients fast-track their submission to FDA and other regulatory agencies.

The Process

At Cigniti, we help transform an innovative design into a reliable and successful product with our independent verification & validation (V&V) practices. Our V&V services include an end-to-end test life cycle offering involving process, people and tools. We provide test design, execution, and documentation by employing a proven quality program that helps our clients achieve multiple business benefits:

  • Faster Time to Market – Device agnostic automated testing framework that accelerates the entire V&V process while reducing the time to market
  • Accelerate Regulatory Approval – Extensive working knowledge of regulatory approval process, and associated guidelines/checklists and our pre-certification testing helps accelerate regulatory approval process
  • Cost Savings – Virtual/simulation testing models, latest tools & technologies, and cost-effective regression cycles
  • Certified Resources – Strong pool of testing resources with knowledge of Medical Devices and associated industry compliance regulation and certification requirements

To detect flaws in the design of medical devices and their shortcomings at early stages saving unnecessary costs of re-designing, and to mitigate risk by conforming to quality standards & regulations, write to info@cigniti.com.