We follow SOP to do the right things and do things right
We implement SOPs according to ISO 13485, from feasibility, planning, development, verification, to validation, our every work is traceable to ensure the design meets its specifications, and the product meets its requirements. We have practical experience in Class-C software which conforms to IEC 62304.
We provide one-stop service of comprehensive medical devices solutions
• Customised for our customers
• Improving existing products
• Advising on feasibility of new products
• Designing initial product concepts
• Developing prototype
• Assisting with FDA licensing process
• Handling mass manufacturing
• Improving existing products
• Advising on feasibility of new products
• Designing initial product concepts
• Developing prototype
• Assisting with FDA licensing process
• Handling mass manufacturing
Our product development service includes:
• Mechanical design
• Hardware design
• Software design
• System integration design
• Verification
• System integration test
• Regulation & reliability test
• Production tools design
Altek Medical assists customers in completing its FDA registration filing throughout the entire process (subject to supporting documents to be provided)
• Hardware design
• Software design
• System integration design
• Verification
• System integration test
• Regulation & reliability test
• Production tools design
Altek Medical assists customers in completing its FDA registration filing throughout the entire process (subject to supporting documents to be provided)
