Our phase-gated design control, services overview, and case studies from ideation to launch.
A structured approach to medical device development following industry best practices and regulatory requirements through five comprehensive phases.
Foundation setting with strategic planning and early assessment
Validation of concept with prototypes and testing
Full-scale development with regulatory preparation
Comprehensive testing and regulatory readiness
Continuous monitoring and improvement post-launch
Our comprehensive phase gate process ensures regulatory compliance and quality excellence at every stage.
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Business case
Clinical review and Human Factors, ISO 62366
Concept development
IP and Patent filing
Concept development, rapid prototyping
System design, detailed designs
Key Opinion Leader feedback
Program Management :Phase gated approach
CFR: 820.30 ISO 13485
Device Design, Packaging Design
Human Factors and Usability
Sterilization Process Development
Validation and Verification
ISO 62366
ISO 14971
Design History File
Company registrations
Design and validation
Class I, II, III
510(K), PMA, NDA
Global registrations
System architecture
Clinical review and Human Factors, ISO 62366
Concept development
User centered concept: Voice Control, Human Touch, Ai
Detailed embedded S/W
PCBA layout and fabrication
Mixed signal electronics and Power
C++, Python - - -
Hazard analysis
Design History File
Automated Test Systems
EMI, Safety Design and validation
HIPAA/GDPR compliance
510(K), PMA, NDA
ISO 62304
Integrated platform
Connected devices
SaMD: Software as a Medical Device
Wearable Devices
Preoperative: Diagnostic data to core unit
Intraoperative: Core unit to the cloud servers
Postoperative: Mobile custom app, iPAD, email
Total stack solutions
Mobile app
Cloud platform: AWS, Azure - - -
Sterilization Process Development
Data Analytics
AI/ML
Customer focused
Agile and GIRA
Clinicians and Customers
Continuous improvements
HIPPA, GDPR and Penetration Testing
Identify potential use cases, evaluating their feasibility & impact and prioritizing for development.
Develop roadmap to integrate AI/ML solution into business operations and strategy.
Involves defining strategy for AI/ML initiatives, identifying use cases, resource allocation.
Designing and planning AI/ML technical architecture considering organization's need.
To help businesses modernize their AI infrastructure, optimize performance, and ensure scalability.
Model packaging, deployment strategy and infra set up.
Pipeline automation, Model Re-training and lifecycle Management.
Drift detection, performance monitoring, Tooling & security.
Design, develop and deploy solution tailored to client's specific need
RAG, Chatbot, Summarization, Information Retrieval, Search, Content Creation.
Identification of repetitive tasks, processes where manual intervention is required.
Identify bottlenecks, inefficient processes, analyze data to uncover problematic area and then implement AI models to optimize.
info@healthcareevolution.com
Book a strategic planning session to discuss your medical device development needs.
We respect the sensitive nature of healthcare innovation and are prepared to sign NDAs before detailed technical discussions.