Proven Process Medical Devices, Design, Development, Testing, and Manufacture

WHO WE ARE

OUR EXPERIENCE

• FDA Class II and III therapeutic and

diagnostic device product

development and manufacturing

• A mature, well developed ISO 13485

quality system

• Efficient and effective, Best-in-Class

for rapid Time-to-Market

OUR FOCUS

• Exclusively focused on medical

devices since 1994

• Medical capital equipment, patient

monitoring, implantable and

disposable devices, in-vitro

diagnostics

• Success with devices in accordance

with FDA, EU MDD, AIMDD and

IVDD

WE ARE TRUSTED

• Customers Include Industry Leaders and

Emerging Companies

• High Customer Return Rate

• ISO 13485:2003 Certified

• FDA Registered & Successfully Audited

STAFF RESOURCES

• Engineering

Development

Quality

Manufacturing

• Quality Assurance

• Regulatory Support

• Manufacturing

MAJOR MARKETS SERVED

• Medical Robotics

• Drug Delivery Devices

• Cardiac Assist

• Cardiac Rhythm Management

• Neuromodulation / Pain Management

• Patient Monitoring

• In-Vitro Diagnostic Devices

• Catheters

• Vascular Access Devices

• Minimally Invasive Surgical Devices

• Instrument Reprocessing Equipment

• Combination Devices

WHAT WE DO

DESIGN &

DEVELOPMENT

VERIFICATION

& VALIDATION

CONTRACT

MANUFACTURING • Pilot & Full Scale

Manufacturing

• FDA Registered

• ISO 13485 Certified

Concept to Customer ℠

• Product Verification &

Process Validation

• Domestic &

International

Compliance

• Product Definition

• Concept Design

• Prototype

Development

• Design for

Manufacturing

DESIGN & DEVELOPMENT

MECHANICAL ENGINEERING

• Mechanical / Electro-Mechanical

Mechanisms

• Molded and Extruded Components &

Devices

• Macro and Micro Fluidics Components

• Pneumatics

• Biocompatible Materials Selection

• Finite Element Analysis

• Computational Fluid Dynamics Analysis

• Sterile and Non-Sterile Packaging

• Rapid Prototyping

ELECTRICAL & ELECTRONIC ENGINEERING

• IEC 60601 Medical Grade Electronics

• Physiological Data Acquisition

• Embedded Microprocessor Devices

• Application Specific Integrated Circuits

(ASIC, FPGA, Gate Array, etc.)

• Wireless Communication Including

Inductive, MICS, Bluetooth, and 802.11

• Digital Signal Processing (DSP) Solutions

• Printed Circuit Board Design

• Battery Operated and Low Power Devices

• Motor and Motion Control

• Analog and Digital Design and Simulation

SOFTWARE DEVELOPMENT

• Medical Grade Software Development

using ANSI / IEC 62304 Lifecycle

• Compliant with FDA Guidance’s and

International Standards

• Major Languages Include C, C++, C#,

Visual Basic, and Assembly Languages

• Software for Windows, Linux, QNX and

Other Major RTOS

• Embedded Microprocessor

Software / Firmware

• Digital Signal Processor Software

• Automated Test Equipment Software

• Independent Software V&V

PRODUCT DESIGN AND PROCESS

VERIFICATION & VALIDATION

• Verification & Validation Planning

• Risk Management per ISO 14971

DESIGN VERIFICATION

• Functional and Performance Verification

• Environmental Testing

• Biocompatibility Verification per ISO 10993

• Sterility Verification per ISO 11607

• Electrical Safety and EMC per IEC 60601

• Packaging Transit Verification per ASTM

or ISTA standards

• Software Validation

• Equipment IQ / OQ / PQ

• Process FMEA

• Validation of Special Processes

• Process Capability Analysis

FABRICATION & ASSEMBLY

PROCESS VALIDATION

CONTRACT MANUFACTURING

• FDA Registered and ISO 13485 Certified

Manufacturing and Capability

• Mechanical and Electronics Assemblies

• Disposables

• Sterile and Non-Sterile Packaging

• Medium Volume / High Mix Production

Assembly

• Incoming Inspection and Warehousing

Controls

• Enterprise Resource Planning (ERP)

Tracking

• Supply Chain Management Including

Approved Supplier Program

OUR PROVEN PROCESS

PROJECT MANAGEMENT PROCESS

• Project Management Starts at the

Proposal Phase

• Free Initial Consultation to Determine

Customer Needs

• Detailed Project Planning Model

Developed for Proposal and Initial

Project Tracking

• Collaborative Review and Fine Tuning of

the Model with Customer to Properly

Align Project Plan with Customer’s

Needs

• PPMD Can Manage Multiple Groups

Globally

PROJECT MANAGEMENT PROCESS

• Dedicated Project Teams Assigned

to Customers

• Weekly Status Tracking Meetings, Using

Web Conferencing for Remote

Participants, for Each Project

• Utilize Project Management Controlling

Metrics Including Milestone and

Cost Tracking

• On Site Conference Facilities Available

to Customers

MEDICAL DEVICE PORTFOLIO

• Concept to Customer Development and

Manufacturing

• Precise Pneumatic Control

• High Reliability

CRITICAL LIFE SUPPORT SYSTEM

• Paradigm Shifting Technology Platform

• Precise Motion Control

• Ergonomic User Interface

• Complex Systems Integration

REMOTE & ROBOTIC DEVICES

• Precise Fluid Control

• Power Injection

• Ergonomic User Interface

• Complex Systems Integration

• IEC 60601-24 and FDA Infusion Pump

Guidance Compliance

FLUID INJECTION AND MEDICATION

DELIVERY PRODUCTS

• Concept to Customer Development and

Manufacturing

• Complex Electro-Mechanical Fluid Handling

• Implantable Microelectronics

• Novel Implantable Materials

• Integrated Medical Grade Software

PROGRAMMABLE & CONSTANT

FLOW IMPLANTABLE PUMPS

• Intuitive User Interface

• Bi-Directional Wireless Communication

• Patient Data Retention

HAND HELD MEDICAL DEVICES

• Continuous Physiological Monitoring (Blood

Glucose)

• Wireless Communication

• Ultra Low Power

• Medical Grade Software

HAND HELD MEDICAL DEVICES

• Product Development and Validation

• Low Cost, High Volume Disposable Systems

• Design for Automated Assembly and Test

DISPOSABLE ELECTRONIC &

ELECTRO-MECHANICAL DEVICES

• Product Development and Validation

• Low Cost, High Volume Disposable Systems

• Design for Automated Assembly and Test

DISPOSABLE ELECTRONIC &

ELECTRO-MECHANICAL DEVICES

• Product Development and Validation

• Low Cost, High Volume Disposable Systems

• Design for Automated Assembly and Test

DISPOSABLE ELECTRONIC &

ELECTRO-MECHANICAL DEVICES

• Catheter Material Selection

• Metal and Plastic Port Bodies

• Proprietary Interconnects

• Pressure & Flow Characteristics Optimized

with CFD

• Sterile Package Design

CATHETERS, VASCULAR ACCESS

PORTS, STERILE KITS

• Concept to Customer Development and

Manufacturing

• Complex Electro-Mechanical Fluid Handling

• Closed Loop Control Using Fluid Level,

Pressure, Temperature and Ozone Feedback

• Medical Grade Software

PARADIGM SHIFTING CLEANING

& STERILIZATION EQUIPMENT

CLASS II & III MEDICAL DEVICE

CONTRACT MANUFACTURING

Thank You

For more information please contact

Mike Kanis

(508) 261-0849

mkanis@provenprocess.com