Our Consultation Services for Medical Device Establishments
We provide comprehensive consulting services to guide aspiring entrepreneurs through the entire journey of establishing a successful medical device company. From market research and business plan, laying infrastructure, design and legislation to product release, our experts will support you every step of the way.
From Scratch to Commercialization
Our services cover the full spectrum, from initial concept development to final product commercialization. This includes branding, marketing, and all the critical technical steps in between to bring your medical innovation to market.
Concept
We’ll help you transform your idea into a viable product with thorough market research and strategic planning.
Design
Our experts will guide you through the design and development process, ensuring your device meets regulatory standards.
Launch
When your product is ready, we’ll support you with comprehensive branding, marketing, and go-to-market strategies.
Market Research and Key Product Selection
Identifying the right product opportunities is crucial. We’ll conduct in-depth market research to pinpoint unmet needs and help you select the most promising medical device for development.
Competitive Analysis
Understand your market landscape and identify gaps that your company can fill.
Product Portfolio Assessment
Provide feasibility based on market needs and select the exact infrastructure requirements through this analysis.
Regulatory Landscape
Factory Layout and Establishment
A state-of-the-art clean room is essential for medical device manufacturing. We’ll work with you to design and set up a compliant, efficient clean room facility with all auxiliary sites tailored to your production needs.
Controlled Environment
Maintain strict temperature, humidity, and air quality standards to prevent contamination.
Specialized Infrastructure
Incorporate the right filtration systems, airflow patterns, and materials for your clean room.
Regulatory Compliance
Ensure your clean room meets all relevant industry regulations and guidelines.
Equipment and Machinery Selection
Choosing the right equipment and machinery is crucial for efficient, high-quality medical device production. Our experts will help you identify, procure, and install the necessary tools and systems.
Precision Instruments
Select advanced tools and machines for accurate, repeatable manufacturing processes.
Solutions for Budget and Need
We understand that automated or high-tech solutions may not always be necessary. Our goal is to provide the necessary equipment and machinery based on market and company needs, all within project budget.
Maintenance and Support
Ensure your equipment is properly maintained and serviced for long-term performance.
Validation and Optimization
Rigorous validation and continuous process improvement are essential for medical device manufacturing. We’ll work with you to validate your machines, processes, and systems, and optimize them for maximum efficiency and quality.
Qualification
Verify that your equipment, facilities, and processes meet all requirements.
Validation
Demonstrate that your manufacturing processes consistently produce devices that meet specifications.
Optimization
Refine your operations to enhance productivity, reduce waste, and improve quality.
Quality Management and Documentation
Ensuring a robust quality management system and comprehensive technical documentation is crucial for medical device compliance. We’ll provide expert guidance to help you establish and maintain these critical elements.
QMS SOPs
Develop and implement quality management procedures, from design to post-production.
Design Controls
Implement rigorous design controls to ensure your device meets all requirements.
Technical File
Compile a complete technical file with all necessary product and process documentation.
Employment and Institutionalization
Building a talented, well-trained team is essential for the long-term success of your medical device startup. We’ll help you recruit, onboard, and develop the right personnel to drive your operations forward.
Leadership
Identify and cultivate strong leaders to guide your organization’s vision and strategy.
Teamwork
Foster a collaborative, cross-functional culture to support innovation and problem-solving.
Training
We will provide comprehensive training programs to ensure your team’s skills are sharp and knowledge stay current.