Braemac Solutions for Medical Applications
Medical OEMs face challenges in designing, getting medical products to market.
- Long design cycle
- Regulatory approvals (US FDA, EU, others)
- Finding components with 5-10 available life
- Researching pre-certified components
- Low failure—medical is mission critical
Braemac can help select components that pre-approved, meet the stringent criteria for medical applications.
Common Features Requests
- Meet IEC 60601-1 & EN 60601-1 Standard for USA, EU
- ISO 13485:2016 certification for finished products
- Power supplies – patient contact, non-contact options
- End displays – options for washable and gloved operation
- Computing – Privacy/HIPAA compliance, bedside, cart, critical applications