Intertech Engineering Associates, Inc.

Medical Device Design & Development

Why Intertech is the RIGHT choice for your Company:

For over 30 years, Intertech Engineering Associates, Inc. has exclusively focused on the design, development, validation, and verification of medical devices and equipment. Designing medical devices is very different from designing consumer devices due to the maze of regulations, guidance documents, and standards. An engineering company that is less experienced in medical devices (i.e. a commodity engineering company) may promise more and charge less, but as the saying goes; if it seems too good to be true, it often is. Intertech, with decades of medical device and regulatory compliance experience, will partner with you, do the job once, and do it right.

Intertech packages all that expertise and experience in a wide array of Design & Development services to suit your needs. We have Embedded Software and Hardware expertise to handle any problem. We will work with you to determine your needs and develop a plan for how we can help. A short list of our most popular service packages includes:

  • Turn-key development – taking a device from concept through validation
  • Engineering Resources to staff-up an ongoing project
  • Device Maintenance (including Reverse Engineering for existing devices)
  • Project Management, Scheduling and Planning
  • Compliance and Standards Consulting (FDA, IEC, IEEE)
  • Rescue Missions - join troubled projects to put them back on a path to success

Driven by Intertech’s adherence to a vetted Quality System and backed by a competent staff whose longevity with the company is legendary, the choice is clear. Intertech will help you reach your goals and get your product out the door.

For more information on why you should choose Intertech click here.


Examples of our Work

Medical Device Design & Development Capabilities

Service Offerings
Hands-on Project Participation
  • Turn-key Development
  • Design Enhancement
  • Troubleshooting and Debugging
  • Compliance Remediation
  • Reverse Engineering & Retro-documentation
  • Project Turnarounds Project Management
Training
  • AAMI Certified Trainers and Courses
Coaching
Project and Product Evaluations
Device/Corporate Due Diligence
Expert Witness Services
Design & Development Engineering Expertise
Systems Engineering
Electrical Engineering
Software Engineering
GUI Design & Implementation
Compliance Engineering
Systems Engineering Expertise
Project Planning
Design History File Creation and Maintenance
Configuration Management
  • Surround SCM
  • CVS
  • Subversion/SVN
  • Visual Source Safe
  • Agile Document Control
Defect and Issue Management
  • Test Track
  • Bugzilla
  • Redmine
  • JIRA
Systems Requirements Development
Systems Requirements Review
Traceability
Systems Requirements Management
  • IBM Rational DOORS
  • Siemens Teamcenter
  • TestTrack RM
Risk Management Plans
Risk Management File Creation and Management
Safety Assurance Cases
Electrical & Electronics Hardware Expertise
Design Reviews
PCB Layout
Orcad Schematic Capture
VHDL
Circuit Simulation
Modeling
Test Fixture Design & Harness Development
Manufacturing Test Platforms
Prototype Assembly
Documentation for Regulatory Compliance
Microprocessor & Other Component Selection
Fluid Management
Design for Manufacturability
Transfer to Manufacturing
Software Expertise
Software Development Planning
Software Requirements Development
Software Requirements Review
Software Architecture
Multi-Processor Architectures
Distributed Computing
Detailed Design & Documentation
Code Reviews and Walkthroughs
Coding Standards Development
Virtualization
Communication Protocol Design and Document
Hardware-Software Integration & Interfacing
Software Implementation
  • C
  • C++
  • C#
  • Assembly
  • .NET
  • Win32
  • MFC
  • COM
  • Visual Basic
  • Java
  • Ruby
  • Python
  • Perl
  • OpenGL
  • PEG
RTOS (Real Time Operating Systems)
Nucleus
Micrium uC/OS-III
Quantum Leaps QP/QEP
Windows CE
Ground Up Kernel Design
Windows XP/7/8/Embedded
Linux
Development & Modeling Software Tools
IAR
Green Hills
MPLAB
Visual Studio
LabVIEW
NI-DAQmx
SolidWorks
PSpice
Development Test Tools
CSUNIT
Typemock
Cantata++
Source Monitor (Complexity Metrics)
PC LINT
Processors
ARM Core/Cortex
PIC16/24/32
Motorola
Intel x86
MSP430
Analog Devices - Blackfin
Communication Protocols
SQL
Wi-Fi
Bluetooth
TCP/IP
CAN bus
RS232
RS485
USB
I2C
SPI
DSP
RFID
Industry Standards
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-8
IEC 60601 2-24
IEC 62366
ISO 13485
ISO 14971
IEC 62304
AAMI TIR 32
AAMI TIR 36
AAMI TIR 45
IEC 80001-1
IEC/TR 80002-1
MISRA C Standards
FDA Regulations & Guidance Documents
General Principles of Software Validation
Design Control Guidance for Medical Device Manufacturers
Quality Systems Regulations (QSRs) 21 CFR 820
Part 11 Regulation Electronic Records & Electronic Signatures
Medical Device User-Safety: Incorporating Human Factors Engineering into Risk Management
Off-the-Shelf Software Use in Medical Devices
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Quality System Information for Certain Premarket Application Reviews
Guidance for Industry Computerized Systems Used in Clinical Investigations
Total Product Life Cycle: Infusion Pump – Premarket Notification [510(k)] Submissions (Draft Guidance)
21 CFR Part 880
  • General Hospital Personal Use Devices
  • Reclassification of Medical Device Data System Mobil Medical Applications
Guidance for Industry and FDA Staff

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