3D Modeling & CAD Design:
Expert development of precise 3D models using advanced CAD software (AutoCAD, SolidWorks).
Creation of 2D drawings with detailed Geometric Dimensioning and Tolerancing (GD&T) for manufacturing accuracy.
Design Failure Mode and Effects Analysis (DFMEA):
Comprehensive DFMEA to identify potential design flaws and mitigate risks early in the development process.
Bill of Materials (BOM) & Assembly Instructions:
Detailed creation of BOMs and step-by-step assembly instructions to streamline the manufacturing and assembly process.
Rapid Prototyping:
Development of functional prototypes for testing and validation, ensuring the design meets user needs and regulatory requirements.
Test Protocols & Method Validation:
Custom development of test protocols to validate the performance and safety of your product, in line with industry standards.
Material Selection:
Expertise in selecting biocompatible materials that meet medical device standards and ensure product safety and efficacy.
Precision Production:
Offering comprehensive manufacturing services with a focus on delivering high-quality, precision-engineered products. From small-batch to larger-scale production, we ensure every product meets stringent quality standards.
Design for Manufacturing & Assembly (DFM/DFA):
Optimizing designs to enhance manufacturability and ease of assembly, reducing production costs and time.
Quality Management:
Rigorous quality control throughout the manufacturing process, ensuring consistent product quality and adherence to regulatory standards.
ISO 13485 Quality Management:
Guidance on aligning your product development process with ISO 13485 standards, ensuring quality and regulatory compliance.
IEC 60601 Safety Requirements:
Ensuring your product meets IEC 60601 safety standards for medical electrical equipment, with a focus on electrical safety, performance, and reliability.
Design History File (DHF) & Compliance Documentation:
Preparation and review of comprehensive DHF and other regulatory documents, ensuring readiness for regulatory submissions.