EXPERTISE OFFERED:

Consulting

Software Verification and Validation

Software Quality Assurance

Design Control

Software Hazards Analysis and Risk Management

Product and software development process in industry regulated environment

Independent SW Audit

Leadership

Team Building

Mentoring

Interim Management

Successful experience with ISO, FDA, QSR, TÜV, SEI, CMM, IEEE

History of consistent project completion on schedule, within budget and with exceptional quality

Engineering

Hands-On Regulated Industry Activities and Deliverables

Software Life Cycle

Embedded Processors Firmware

Documentation Services

Due Diligence

Software Section for 510(K), IDE, PMA and CE Mark Preparation

WORK HISTORY:

Consulting Business Owner, Mira CLE (2005 – present):

· Triage Wireless: SW Life Cycle and SOPs; SW Verification and Validation

· McKesson: Due Diligence

· DermTech:

o SW Verification and Validation Lead

o Workflows Definition & Validation

· Digene: SW Verification and Validation package

· The RND Group: SW SOPs; SW Verification and Validation package

· Photothera:

o Embedded SW Verification and Validation

o Preparation of IDE and PMA Submission

o NEST-2 Clinical Trial Support

· Life Sciences IT Global Institute:

o Working Group Leader for GIP Guidance Document

o Validation and Verification Chapter Lead

· Invitrogen Corporation:

o Agile Quality Management System Validation

o Workflows Definition and Validation

Sr. SW Verification and Validation Manager, Gen-Probe (2002-2005)

R&D Program Director, Alaris Medical Systems (1997-2002)

SW Engineering Manager, Medtronic (1994 - 1997)

Quality Assurance Manager, Infrasonics (1992 - 1994)

Principal SW Engineer, IMED (1988 - 1992)

MIRA MILOVANCEV Page 2 of 2

EDUCATION:

University of Belgrade, Serbia

Electronic and Telecommunications

Major: Computer Engineering

Title: Graduated Engineer of Electronic and Telecommunications
(Equivalent to a Masters Degree earned in the US)

SUPPLEMENTAL DETAILS:

Instruments:

Infusion instruments: Asena (ALARIS, UK), Signature Edition (ALARIS, USA), Gemini (IMED); MedSystem III (IVAC); Medipak (Baxter - Medication Delivery Devices)

Open heart surgery: Heart-lung machine Cornerstone (Medtronic Bio-Medicus); Cardioplegia Safety System (Medtronic Bio-Medicus)

Lung respirators: Adult Star (Infrasonics), Pediatric Star (Infrasonics)

Diagnostics: TIGRIS (fully automated in-vitro molecular diagnostics instrument to screen for hepatitis, HIV, West Nile virus; Gen-Probe, San Diego); hc2 (Hybrid Capture) System (Digene, Gaithersburg, MD)

Miscellaneous: A-Line (depth-of anesthesia monitor, Denmark); TriOn (concept for anesthesia suite, ALARIS, UK); NeuroThera (laser-based treatment for ischemic stroke) – undergoing clinical study

Standards: FDA, IEEE, ISO, SEI, CMM

Life Cycle Deliverables, Actions And Achievements:

Software Quality Assurance area: SW Quality Assurance Plan, Software Compliance Assessments, Quality SOPs and templates customized to fit individual customer’s size and needs, Software Verification & Validation (V&V) Plan, Unit Test Plan, Integration Test Plan, Test Scripts, Software V&V Report

Software Development area: Software Development Process Definition and Training, Product Development Process, Development SOPs and templates customized to fit individual customer’s needs and size, SW development metrics, SEI level 3 organization

Hands-On SW Development area: drivers for various hardware components (audio, keypad, graphic displays, interrupt handlers), operating system and task scheduler for critical-size embedded devices

Design Control area: Product Development Plans, SW Development Plans, Customer Needs Document, Requirements Document, Specification Requirements Document, Design Review documentation, Traceability Matrix, Verification and Validation documentation, Design Transfer documentation, Post-Market Surveillance Plan and Report, SW Configuration Management, Design History File

Software Hazard Analysis and Management area: Risk Assessments, Hazard & Risk Analysis, SW Fault Tree Analysis (FTA), Failure Modes & Effects Criticality Analysis (FMECA & FMEA)

Documentation Services area: Created or reengineered a wide range of documents following FDA and ISO regulatory requirements, and IEEE standards

Audit area: certified internal quality auditor for processes, deliverables, suppliers, following FDA/ QSR, QSIT, ISO 13485

Regulatory and Compliance area: averted pending consent decree, established processes necessary for a European facility to sell products to the USA market, successfully dealt with 483, prepared SW section for 510(K), IDE, PMA & CE Mark Submissions