Below are some of the larger companies in industry offering medical and instrumentation electronics contract manufacturing outsourcing services.
- Benchmark Electronics
- Celestica
- Flextronics
- Jabil Ciruit
- Plexus
- Sanmina-SCI
While Sanmina-SCI currently earns the largest amount of revenues from this market segment, Plexus, though a smaller contract manufacturer in total revenues, derives a much larger percentage of its total company revenues from the sector.
Some of the products Sanmina-SCI provides services for in the medical and instrumentation space include:
- nuclear magnetic resonance imaging (NMRI) equipment
- vascular imaging equipment
- diagnostic equipment
- therapeutic and laboratory equipment (which includes products in anesthesiology monitoring, dialysis, and ophthalmic)
Some of the products Plexus provides services for in the medical and instrumentation space include:
- diagnostic imaging
- RF ablation
- glucos monitoring
- ultrasound diagnostic and surgical instruments
Contract manufacturers providing services in this space must have their facilities certified by the FDA. Contract manufacturers in this space should have extensive knowledge in, and be able to provide valuable guidance with, product regulatory requirements such as Pre-Market Notification (PMA or 510(k)) as well as Notified Body submissions for CE Mark compliance. Other important agency compliance and quality/regulatory experience includes:
Agency Compliance
- UL & cUL, CSA
- JMHW
- IEC
- FC
Quality/Regulatory
- FDA, QSR
- ISO 9001, 9002
- EN 46001, 46002
- FDA Class I, II, III PMA
- CE Mark I, IIA, IIB, III
VentureOutsource.com, April 2006
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