BMDK pools its large resource base consisting of the parent company, offshore centers and partners to provide engineering services in the following areas:
Contract Manufacturing
BMDK specializes in assembling electro-mechanical devices as well as sterile,
single-use accessories. For your convenience we offer:
- In Process Electrical/Electronic Testing
- Controlled Environment Assembly Room
- Final QC Inspection
- Storage and Warehousing Engineering
Analysis and Design
- 3-D Modeling
- Finite Element Analysis
- Thermal Analysis and Heat Transfer
- Prototyping
- Detail Engineering
Medical Electronics Engineering
- Digital and Analog Circuit Design
- Hardware Design
- PCB Layout
- Power Electronics Short-Range
- Wireless Systems
- Sensors and Imaging Technology
Software Development
- System Analysis and Design
• Embedded Application
• Database Oriented Design and Development
• Wireless Application Design and Development - Integration
- Testing
- Implementation
QA and Regulatory Services
We are registered and qualified with the FDA as a Medical Device Establishment. Our Quality System complies with FDA and follows the spirit of the ISO 13485 standard. We provide following services to other medical device companies and start-ups:
- 510(K) Assessment
- Development of Written Argument for Substantial Equivalence
- Identify Applicable FDA Guidance Documents
- Prepare and Submit 510(K)
- Develop IDE application
- Assistance Throughout PMA Process