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Our History
Founded in 1995, DAFFYS CONSULTING INC has been providing exceptional medical services to our community for over 25 years. We have grown and expanded our services to meet the ever-changing healthcare needs of our patients.
DAFFYS CONSULTING INC - Precision,partnership,progress
Our Technology
Our Partnerships
Our Partnerships
We are committed to staying up-to-date with the latest medical technology, including our expertise in 3D OEM for medical devices, to ensure that our patients receive the best possible care. From advanced diagnostic tools to healthcare consulting, we invest in the latest technology for our patients, including medical devices marketing and
We are committed to staying up-to-date with the latest medical technology, including our expertise in 3D OEM for medical devices, to ensure that our patients receive the best possible care. From advanced diagnostic tools to healthcare consulting, we invest in the latest technology for our patients, including medical devices marketing and OEM services. Additionally, our focus on orthopedic implants outreach allows us to provide specialized solutions tailored to patient needs.
Our Partnerships
Our Partnerships
Our Partnerships
We partner with other healthcare organizations and community groups to provide comprehensive healthcare consulting services, including 3D OEM for Medical Devices. Our collaborations enhance our ability to deliver a range of resources and services, such as Medical Devices OEM services and support for Orthopedic Implants outreach, ensuring
We partner with other healthcare organizations and community groups to provide comprehensive healthcare consulting services, including 3D OEM for Medical Devices. Our collaborations enhance our ability to deliver a range of resources and services, such as Medical Devices OEM services and support for Orthopedic Implants outreach, ensuring our clients receive integrated solutions tailored to their needs in the Medical Devices Marketing space.
ABOUT US
Revolutionizing Healthcare Through Expert Consulting
We guide healthcare innovators—from startups to hospitals—through medical device development, 3D manufacturing, regulatory pathways, and AI-driven solutions.
With a multidisciplinary approach, we help bring high-impact, patient-centric innovations to market—efficiently and compliantly.
Who We Are
A team of consultants, engineers, and regulatory experts committed to delivering safe, innovative healthcare technologies to market.
From ideation to commercialization, we align clinical needs with technical feasibility and global regulatory standards.
Our Services
1. Medical Device Marketing
Targeted strategies to boost product success:
• Market research
• Launch execution
• KOL engagement
• Digital campaigns
• Partner outreach
🔹 We develop data-driven marketing strategies tailored for niche medical markets and ensure product visibility across digital and clinical ecosystems.
🔹 Our team connects you with key opinion leaders (KOLs) and distribution channels to accelerate adoption.
2. 3D Manufacturing & Prototyping
Fast, compliant prototyping and production:
• Biocompatible materials
• Custom implants & tools
• CAD design
• ISO 13485 processes
🔹 We transform clinical concepts into precision-engineered, patient-specific 3D models and prototypes within days.
🔹 All solutions comply with medical-grade manufacturing standards and are optimized for scalability.
3. Regulatory Compliance
Reliable global regulatory navigation:
• FDA 510(k), PMA
• CE, MDR, IVDR
• ISO 14971 risk protocols
• Technical documentation
• PMS & audits
🔹 Our experts prepare robust regulatory submissions that meet country-specific requirements and reduce time-to-approval.
🔹 We manage post-market surveillance, technical files, and audits to maintain long-term compliance and minimize risk.
4. Healthcare IT Consulting
Technology to enhance care and efficiency:
• EHR/EMR integration
• HL7, FHIR, DICOM
• HIE architecture
• HIPAA/GDPR compliance
• Custom IT solutions
🔹 We streamline clinical workflows through custom healthcare IT solutions that ensure data interoperability and regulatory security.
🔹 Our team ensures seamless integration with existing health infrastructure while maintaining strict privacy compliance.
5. AI & Machine Learning
Smarter systems for better outcomes:
• Predictive analytics
• AI-powered imaging
• NLP for clinical data
• ML-driven treatment
• Regulatory-ready AI tools
🔹 We design AI models tailored for diagnostics, treatment personalization, and predictive healthcare trends.
🔹 Our solutions are built with regulatory foresight, ensuring they are audit-ready for FDA and CE submissions.
Who We Serve
• Medical Startups – We help transform ideas into market-ready innovations with technical, regulatory, and commercialization support.
• Hospitals & Clinics – From digitization to device integration, we enhance patient care and operational efficiency.
• Health Tech Companies – We provide scalable solutions to accelerate tech-enabled healthcare delivery.
• Bioengineering Labs – Prototype validation, material selection, and regulatory alignment for cutting-edge biomedical research.
• Pharma & Biotech – We support drug-device combination products and digital therapeutics with a focus on compliance and innovation.
• Regulatory Affairs Teams – Documentation, submissions, and audits simplified through expert regulatory consulting.
Why Choose Us?
✅ Deep Industry Expertise – Decades of experience across clinical, engineering, and regulatory verticals.
✅ Global Regulatory Mastery – Expertise in navigating complex FDA, CE, and international approvals with precision.
✅ Agile Manufacturing Integration – In-house 3D prototyping aligned with ISO standards for rapid, custom production.
✅ AI & IT Implementation – End-to-end solutions from system design to deployment of compliant healthcare AI.
✅ Scalable, Customer Service – Personalized consulting that adapts to your project stage, goals, and global expansion needs.