MEDICAL MARKETS

Overview:

Medical

Key Electronics is primarily engaged in the Medical market sector with the manufacturing of Class I and II medical devices. It’s understood that introducing new products to market from concept, research and development, regulatory approvals, distribution and production can be extremely time consuming and capital intensive. Key Electronics provides high-reliability manufacturing and program management services to support the customer’s requirements during each stage of medical device market introductions as summarized below:
P H A S E S E R V I C E S
Concept and Feasibility
  • Participate with Prototype Analysis
  • Participate Design FMEA
  • Initiate Design for Manufacturing (DFM)
Design & Development /
Verification & Validation
  • Manufacture Prototype(s)
  • Initiate Labeling Requirements
  • Participate with Design FMEA
  • Finalize Design for Manufacturing (DFM)
  • Assist with Regulatory Submission
  • Plan Supplier Chain
  • Initiate Process Flow Diagram, SIPOC and Control Plan
  • Initiate Process IQ, OQ, PQ, PPQ Initiation
Final Validation /
Product Launch Phase
  • Perform Supplier Audits and Risk Management
  • Participate with final Design FMEA
  • Finalize Label Requirements
  • Assist with Regulatory Approval
  • Perform Design Transfer and New Product Introduction (NPI)
  • Finalize Process FMEA
  • Finalize Process Flow Diagram. SIPOC, and Control Plan
  • Scale Manufacturing / Operations
  • Finalize Process IQ, OQ, PQ, PPQ
  • Execute Manufacturing Service Agreement
Product Launch /
Post-Launch Assessment
  • Perform Quality Audits
  • Develop and Maintain Device History Records (DHR)
  • Evaluate and Implement Process Improvements as needed
Key Electronics has implemented numerous initiatives in support of the Medical market. ISO 13485 Certification and FDA Quality System Regulation (QSR) compliance shows that quality is the number one priority at Key Electronics. The addition of a Class 10,000 Clean Room, recent implementation of duplicate SMT lines and robust process development are further evidence that Key Electronics is prepared and ready for manufacturing medical products.

Key Electronics is a FDA Registered Contract Manufacturer and has a history of providing electronic services to the medical laboratory and medical device markets. This market often requires collaboration with entrepreneurs and companies in the early stages of business maturity. Key Electronics is defined by its pioneer and visionary spirit and will consider partnerships and various business arrangements on a case-by-case basis. Please contact the CEO or CFO to discuss these opportunities in further detail.

Medical Device Experience:
  • Glucose Monitor Calibration Strips
  • Magnetic Resonance Imaging (MRI) PCBA’s
  • Surgical Light Source (Light Emitting Plasma)
  • Surgical Head Light Optics
  • Airway Monitoring Systems
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