What is Quality Systems Consulting & Contracting?

My name is Chris Wood.  I am a Software Engineer and Quality Systems Professional with over 30 years of experience in the Medical Device industry.   

The first half of my career I spent in manufacturing, test, true clinical R & D, software development (maternal / infant care, vital signs monitoring, neonatal monitoring, home apnea monitoring, SpO2 development and perinatal charting and medical record systems.  The remainder of my career has been spent Quality and Regulatory space as a Quality Engineer, QA RA Manager and Director.

I was the QA/RA Design Controls subject matter expert for the Patient Care segment of one of, if not the biggest, Medical Device manufacturers in the world.  That segment included patient monitoring systems (vital signs, neonatal, non-invasive blood pressure, home apnea), anesthesia delivery, diagnostic cardiology, and maternal-infant care solutions).  In addition, I have supported products including nurse call and alarm systems, sleep apnea / CPAPs, and supplemental oxygen devices.

... I have developed and maintained entire quality management systems (QMS), some from the ground up and others supporting new products on the integration of business acquisitions as well as product divestures.

I am experienced in all the relevant aspects of ISO 13485, EU MDR's, MDSAP, Canadian Medical Device Regulations (SOR/98-282) and U.S FDA Title 21 CFR:

• Part 11 Electronics Records; Electronic Signatures
• Part 801 Labeling
• Part 803 MDR
• Part 806 Corrections and Removals
• Part 807 Establishment Registration and Device Removals
• Part 820 QMS & Good Manufacturing Practices    
• Part 821 Medical Device Tracking
• Part 822 Post Market Surveillance
• Part 830 UDI
• Part 860 Medical Device Classification

I have developed, executed and implemented strategies for:

• Computer Software Assurance / Computerized System Validation
• Failure Mode Effects Analysis to ISO 14971
• Software Development to IEC 62304 and IEC 82304
• Complaint Handling
• Corrective and Preventive Action
• Medical Device Reporting (US FDA MDR's, EU MIR's, Canadian CVR's)

I am a RABQSA Certified ISO 13485 Lead Auditor (UL Oriel Stat-A-Matrix).

I have hosted dozens of FDA inspections and Notified Body Audits and conducted proportionally more internal audits globally.