March 23, 2017

The medical market for flex circuits continues to be strong. PFC is ISO 13485 approved. ISO 13485 is a comprehensive quality management system for the design and manufacture of medical devices. ISO 13485 works hand in hand with ISO 9001 but also adds these requirements – specific to the medical device market:

  • market-specific regulatory requirements include 21 CFR 820, the Quality System Regulation for medical devices sold in the United States, enforced by the U.S. Food and Drug Administration (FDA), or the Medical Devices Directive 93/42/EEC, required for doing business in the European Union
  • controls in the work environment to ensure product safety
  • focus on risk management activities and design control activities during product development
  • specific requirements for inspection and traceability for implantable devices
  • specific requirements for documentation and validation of processes for sterile medical devices
  • specific requirements for verification of the effectiveness of corrective and preventive actions

Requests for design, manufacture and assembly of circuits for the medical market PFC are exposed to vary, but cross all applications for the Medical and BioMed markets including Diagnosis, Monitoring and Treatment.

Solutions we provide today include:
CT Scanners
Catheters, Endoscopes
Ultrasound devices
Wearable electronic devices
Biomed testing apparatus
Breast Pumps, medical pumps
Dental equipment and tools
Surgical tools
Medical Imaging products – XRAY
Blood processing
Hearing aids
Smart glasses

The medical electronics market is projected to grow over the next decades by 5-7% CAGR. It depends on which marketing/analyst company you choose to supply your information, but, market numbers range in the $219 Billion by 2024. The bottom line is there will be continued growth in this market.

The reason?

  • Aging population- Baby boomers hitting 65 years old at a rate of 10,000 per day
  • Increase of chronic illnesses – baby boomers
  • Home healthcare
  • Early diagnosis
  • Increase in electronics for diagnosis, therapeutics, and monitoring technologies
  • Wearable electronics
  • Electronic data gathering and record keeping.

Medical market will continue to grow and require flex. The more exposure PFC gets to the market, the better we can support it!