Medical Device Software Validation For MedTech Companies
Our medical device software verification process evaluates your healthcare devices for data integrity and compliance.
Our Valued Customers
Paperless Medical Device Software Validation
Your medical device software verification is done step-by-step to:
- Swap inefficient paper-based documentation with an efficient paperless electronic system.
- Dynamically track the validation process in real time.
- Improve communication between stakeholders ensuring compliance throughout.
Our Services Offered in Validating Software for Medical Devices
Computer System Validation
Computer Systems Validation (CSV) for tools used during SDLC is conducted according to the strategy set by software developers to ensure accuracy, reliability, and consistent performance.
Software Risk Management
Now Software Risk Management is conducted systematically in collaboration with app specialists, software developers, software architects, and other subject matter specialists.
Software Verification & Validation
Protocols are designed according to the identified software requirements and then apt software V&V is done in collaboration with the software developers, software architects, and engineers.
Unit Testing & Integration Testing
Unit testing and integration testing are carried out by the strategy set in collaboration with the software developers and system engineers.
Develop Strategy & Traceability Matrix
Software detailed design is prepared and a strategy is developed to capture SDD. Then the traceability matrix is created according to software requirements to risk mitigations and to verify in its entirety.
Documentation & Architecture Validation
Software requirements are documented in collaboration with the developers using identified client needs and overall system requirements. Software architecture is prepared and validation is performed.
Your Partners in Validating and Verifying Medical Software
Scalability and Interoperability
Scalability and Interoperability
Time and Cost Efficiency
Time and Cost Efficiency
Reliability and Performance
Reliability and Performance
Regulatory Compliance
Regulatory Compliance
Patient Safety
Patient Safety
Case Studies
We helped healthcare providers and entrepreneurs to solve global health challenges. Learn more about how Folio3 Digital Health uses its clinical brains to deliver meaningful solutions to healthcare organizations, institutions, startups, and support networks.
Healthcare Development Tech Stack
We have state-of-the-art technologies to create healthcare solutions that effortlessly integrate with your existing infrastructure while staying ahead of industry trends.
How Our Development Process Works?
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Client Testimonials
Kudos to your team for outstanding work in the discovery phase! Your team understood our business and workflows by asking the right questions and extracting the most useful information. Your team's ownership and results-oriented approach are commendable.
Shaukat Zakaria
CEO at HealthQuest
I appreciate your remarkable work during the recent Laboratory service phase. Your determination, analytical thinking, and continuous efforts were crucial in overcoming challenges and achieving success. I appreciate your help as we collaborate to create fantastic items.
Maker Athian
Founder at iVision
Omar Ali Midani
Co-Founder and President at PureLife Dental
Working with the folio3 team has been a great experience. Your dedication, creativity, and adaptability in overcoming challenges for the Moodology app project are truly commendable.
Azhar Ali
Director At AiGenics
Justyna Wilson
Senior Director eCommerce and Marketing at face reality Skincare
Tracey Hawkins
Founder and CEO at Thriving on the Spectrum, LLC
Team Folio3 brought my dream app to reality, they explained every step to our non technical team professionally. wireframe and design processes were outstanding & they built stunning and perfectly integrated application. I think both patients and clinic will be significantly benefited.
Elizabeth Miazga
MD FRCSC at Saint Michael's Medical Center
Dean and Ayesha Sherzai
Founders of The Neuro Plan
Our Latest
Healthcare Insights
Frequently Asked Questions
- Make a validation plan
- Determine your system requirements.
- Create a validation protocol and test specifications.
- Conduct and document tests.
- Write final report.
Medical device software verification validation and compliance include IEC 62304 which specifies software lifecycle development requirements for medical devices. Compliance with the standard is mandatory in Europe and it is recognized as a consensus standard by the US FDA.
Medical device software validation companies follow the general principles of software validation documentation.