Agile MedTech – Medical Devices Product Development
Our Services
Product Development & Engineering
- Systems, Mechanical, electrical, firmware and software engineering
- Human factors and usability design
- Software for embedded and cloud-connected systems
Prototyping & Manufacturing
- Rapid prototyping (3D printing, CNC, molding)
- Tooling design, PCB manufacturing
- Low-volume production and pilot builds
Business Case Development
- Clinical and commercial viability
- Reimbursement strategy input
- Investor and grant readiness support
Technology Research & Concept Validation
- Market and competitor analysis
- User needs assessment
- Technical feasibility studies
Quality Systems & Regulatory Compliance
- FDA 510(k), CE Marking, Health Canada
- ISO 13485 Setup
- ISO 14971, IEC 62304, IEC 60601 compliance
Training & Support
- QMS adoption and internal audits
- Risk management workshops
- Design control, DHF/DMR updates
- DevSecOps Support
Remediation & Legacy Device Support
- CAPA resolution
- Gaps assessment
- Engineering and Design Changes
Prototyping & Manufacturing Support
From rapid 3D printing and prototyping to injection molding, vacuum forming, sheet metal, extrusions, PCB production, and disposable components, we bring deep expertise to accelerate your build phase.
Regulatory Approvals
We ensure your design and internal processes comply with global medical device regulations, including:
- FDA 21 CFR 820
- ISO 13485
- MDD 93/42/EEC
- IEC 60601, IEC 62304
- ISO 14971
- MDSAP, HIPAA, HL7, DICOM, PACS
- FDA 21 CFR 820
- ISO 13485
- EU MDR 2107/745
- MDD 93/42/EEC
- IEC 60601
- IEC 62304
- ISO 14971
- MDSAP, HIPAA, HL7, DICOM, PACS
- FDA 21 CFR 820
- ISO 13485
- MDD 93/42/EEC
- IEC 60601, IEC 62304
- ISO 14971
- MDSAP, HIPAA, HL7, DICOM, PACS
Quality Systems Training & Certification
We train your internal teams on QMS adoption, preparing them for process audits and helping your organization meet certification requirements.
Testimonials
What Our Clients Say
Hear from MedTech leaders who have transformed their development with Agile MedTech:
Accurate and Trust Results
"Agile MedTech helped us de-risk our new device launch by integrating compliance checks directly into our sprints. Their expertise significantly cut down our time to market."
Anastasia Ayu
Company Name
Accurate and Trust Results
"Our team's productivity and morale have soared since implementing their Agile frameworks. We're now far more responsive to market feedback."
