30 YEARS OF MEDICAL DEVICE EXPERIENCE
IEC 60601-1 3rd Edition Compliance
Compliant SOP Gap Analysis and Creation
(Risk, Usability, Software, Clause 14)
Software Quality Assurance
Leading & Coordinating Multi-Business Projects
Getting Your Product to Market
24 Years Experience Managing Teams, Departments, Divisions, Outsourced Vendors
Budgeting, Product Definition, Assembling and Leading Resources, Planning, Feasibility, Risk Management, Design, V&V, Submission, Stage Gates, Transfer to Mfg
Leading Cross-Functional Teams:
• Globally dispersed (India, Canada, U.S.)
• Embedded Systems with Class III SW
• Pacing, Endoscopy, Drug Delivery, IV
• Scientists, Engineers, Mfg, Verification
• Budgeting, Planning, Communicating
Software Quality Assurance
26 Years in Software Product Development
• Created medical grade agile process
• Led software safety classification analysis
• 62304 compliance audit, SOP upgrades
• Compiling evidence of software validation
• Leading teams new to medical
Transfer to Manufacturing / Cost of Goods
Leading Manufacturing Transfer:
• Cost of Goods Reduction
(Past Successes: -20%, -64%, -58%)
• High Volume Embedded Disposables
• Capital Equipment
• Software, Embedded Systems
• Test Fixture Design & Qualification
• Production Automation Equipment Design
Outsourced Vendor Management
Experience Leading Outsourced Firms
• Hardware, Software, Mechanical Design
• Human Factors Engineering
• Class II, III
• India Engeering Firms
• Training Firms, Test Houses (60601)
30 Years of Experience in Design & Mfg
• How will the product change practice?
• Has the technology really been proven?
• Are they really ready for FDA? Testing?
• What's the team's track record?
• What's the status of transfer to mfg?
• Is the product producible? Reliable?
IEC 60601-1 3rd Edition Compliance
Steps to 3rd Edition Compliance
Gap Analyze & Upgrade SOP'S and Evidence of:
- Risk Management to 14971
- Usability to 62366
- Programmable Devices to Clause 14 / 62304
Complete 3rd Edition Checklists, TRF's, Gap Fill
"Mike has a reputation for getting things done on time and within budget."
"I was very impressed with how you and your team handled this so effectively... Your experience, managerial skill and attention to detail provided the winning formula."
"The work you and your team did on the project was outstanding. I was impressed with your ability to always get the task accomplished with the resources given and the time allotted."
Chief Regulatory Officer
"Mike has extensive experience with medical devices and has a complete knowledge of all regulatory requirements."
"I couldn't have asked for more. I would not hesitate a second to bring Mike into my programs."
VP of R&D
"You're one of the best PM's I've worked with."
Director of Operations
"Best quality we've had. Since adoption [of Mike's life-cycle] we've been on-time with all our commitments."
VP of Development
"These changes are setting the entire tone of operation for our development efforts. Mike did an outstanding job. I couldn't have asked for more."
"You're one of the best managers I've had here."
Design Services Director
"Mike combines deep knowledge of medical device development, manufacturing and regulatory requirements with outstanding leadership and organizational skills."
"I'd like to take the opportunity to personally thank you for your assistance on this project. I made sure my supervisor is aware of your critical significance toward the successful achievement of this project."
"I'm glad we found you."
"Just wanted to thank you for your cool, calm, helpful, peaceful way. Its appreciated."
"Michael did an outstanding job. He has credibility of all members of the project team, management and the vendor. His plans have been a beacon around which the team has rallied."
"Everything you've given us so far has been excellent."
Director of Quality
"I am impressed by the work you provided to [our firm]. It is very thorough!"
"We got cleared!"
"We finally got cleared ... and are compliant. The document [compliance] review went great..."
30 Year Career in Medical Device Product Development
Vice President for Transfer to Manufacturing, Fluidnet
Senior Director of Engineering, Transport Pharmaceuticals
Senior Director of Instrument Development, Medtronic
Program Manager, Boston Scientific Contract
Software Engineering Manager, Medtronic
Senior Principal Engineer, Medtronic
Contract Software Engineer, Medtronic, Guidant
Medtronic Bakken Award
Medtronic World-Class Development Award
• Medtronic: Class III SW - Released single largest application of its kind, 3 months ahead of 18 month schedule. Multiple, international releases.
• Boston Scientific Robotic Endoscopy: Led globally dispersed engineering teams in India, Canada, U.S., multi-business consortium.
• AspenTech: Defined and deployed common software development staged gate process across 350 developers, globally. (RUP)
• Transport Pharma: Developed Class II onychomycosis treatment instrument saving an estimated $1MM in development cost.
• Transport Pharma: High volume disposable Class II embedded device. Reduced COGS by 64%.
• Cross-functional Teams: Leading human factors, regulatory, quality, hw, sw, mech, manufacturing, verification, clinical, outsourced vendors.
21 CFR 820, FDA, TUV, MDD, ISO 14971, IEC 62304, 62366, 60601-1
• Design control compliant SOP's for product development
• 14971 Risk Management SOP's, risk management plans, reports
• Led multiple cross-functional teams through risk analysis, FMEA (HW/SW)
• At forefront of FDA Safety Case Initiative, AdvaMed/AAMI/FDA Mtgs
• Leading firm's to achieve 60601-1 3rd edition compliance
• Upgraded pre-GMP manufacturing SOP's to pass 2009 FDA audit
• Multiple FDA in-person pre-IND, pre-IDE meetings.
• Adapted Agile Software process for FDA compliance
• Developed and delivered design control training including software
• Software Validation.
Compliant Deliverable Matrix
FDA Compliant Agile Process
21 cfr 820 Training
Compliant Mfg Process SOP
Product Development SOP
ISO 14971 Compliant SOP
Software Development Plans
Product Development Plans
Risk Management Plans
Mfg Process Qualification
Major Level of Concern SW
Configuration Management Plan
Software Compliance Audit
Software V&V Plan
IEC 60601-1 3rd Edition Audits
IEC 62366 Usability Audits
IEC 62304 Software Audits
Safety Case Analysis
Gauge R&R Studies
Risk Analysis, Hazard Analysis
Version 3.0, 3.1
• Multiple, successful engagements.
* Liaison with NRTL's: UL, Intertek
* TRF compilation
* SOP Gap Analysis and Upgrades for SW 62304, Usability 62366, Risk 14971, 60601-1 RMF, Clause 14
* Hospital beds
* X-ray systems
* Vascular Imaging Systems
3rd Edition Compliance
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