MEDICAL DEVICE DEVELOPMENT
Concept Through Manufacturing
Development Services
Feasibility Analysis
Design and Prototyping
Regulatory and Manufacturing
Products That Impact Lives
Medical Device Development
Medical device development requires a special team. Design and engineering is just part of the picture. A successful medical device requires significant development documentation, regulatory work, design validation, and more prior to launch. Our medical device development and manufacturing group brings the complete package. From feasibility analysis through manufacturing – and everything in between, we’ve got you covered.
Feasibility & Evaluation
- Requiremenets Capture
- Product Specification Development
- Medical Device Patent Search
- RFP management
Design and Engingeering
- Conceptual Development
- Industrial Design
- Material Research & Spec
- Engineering
- Test Method Development
- DHF Generation
- DFM / DFA / DFx
- Packaging Design
- QA / QC Requirements Development
Design Verification
- Risk Analysis / FMEA
- Design Documentation
- Design Verification Testing
- Detailed Specification
Validation
- Design Validation
- Componenet & Supplier Validation
- Process / Sterilization Validation
- Regulatory Submissions
Design Transfer
- Device Master Record
- Production Ramp
- Lean Production Process
- Packaging and Labelling
- Continuous Improvement Program Initiation
Feasibility Analysis and Design
Our proven team of world-class engineers will take the product through concepting, engineering, prototpying, test planning, and more. We work in conjunction with your team, to ensure that the product comes to life in alignment with your business needs.
Design Verification and Validation
As your project moves into the design verification stage, our engineers and manufacturing teams will work together to characterize product risk, produce the requisite design documentation, oversee testing, and update designs / specifications based on test findings.
Design validation efforts focus on defining the complete product supply chain, qualifying componenet suppliers, validating the sterilization process if applicable, and preparing regulatory submissions.
Design Transfer
As production begins, our team finalizes production labelling and packaging, produces the device master record, implements lean production process, and begins the continuous improvement program specific to the product.
Beyond production startup, our engineering and manufacturing teams are here to support you through product line extensions, continuous improvement, product updates, and more.
Recent Projects
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