Intertech Engineering Associates, Inc.

Medical Device Verification & Validation

Why Intertech is the RIGHT choice for your Company

At Intertech Engineering Associates, Inc., we specialize and are well known for the development, validation, verification, and compliance engineering for medical devices. In order to meet FDA regulations and ISO, IEC, AAMI, and other industry standards and regulations, device designs must be documented and tested. Our engineering services are process driven and are specifically designed to serve the needs of the medical device design industry. Our involvement in the initial stages of development, best assists clients by ensuring that all stages of the design and development process are adequately documented and compliant with regulations, guidance documents and standards. Early involvement is key in keeping costs under control by doing it right the first time. Unfortunately, clients sometimes come to Intertech later in the lifecycle when the development process has already been started and the client finds that the design history file has not been properly maintained. In these cases, we can offer compliance gap analysis and remediation services to put a project back into compliance.

Intertech’s engineers are experienced with verification and validation planning, test procedure development for system, integration and unit level testing. Intertech is also very accomplished at developing test fixtures used to verify the device’s software, hardware and interfaces, or for QC checks during production.

In a more consultative role, Intertech can provide clients with all the engineering, verification, validation, and other design control documentation that will be needed for regulatory submission.
Our experts can assist clients in meeting the requirements of US and international industry standards including ISO, IEC and FDA Medical Device Quality System Regulation. For more information about our medical device validation and verification capabilities, see the table below, or contact us directly.

Intertech offers the following types of verification and validation services:

Full V&V Partner

Intertech can partner with your design engineering team to verify and validate the device design as a critical part of the development process. This provides assurance that the design process has been planned, is progressing according to plan and the product is being designed meets the needs of your stakeholders.

Experienced engineering partner for focused V&V needs

Intertech can support specific client needs, when an immediate experienced resource need arises. For examples of specific needs we can fill, see the table below. Intertech ramps up quickly using the client’s current quality system and procedures, or substituting Intertech’s tried and true processes and procedures to provide a road map to address specific project needs.

Compliance or remediation projects

Because of Intertech’s experience level working with regulators and industry experts, Intertech understands the sense of urgency necessary to address compliance and field issues. Intertech’s experienced resources can define what is necessary to provide V&V and other engineering services to identify the root causes of issues and support their resolution. Naturally this is all completed with the documentation necessary to provide the required “objective evidence”. In a more proactive model, Intertech has experience in identifying and filling gaps in compliance with regulations, guidance documents, and standards (both domestic and international).

Intertech Engineering can:
  • Develop verification and validation(V&V) processes for your Quality System
  • Develop project verification and validation plans that define activities throughout the product life-cycle
  • Develop and/or review verification and validation inputs for completeness, accuracy, consistency, lack of ambiguity, and … testability
  • Integrate standard compliance into the product and process through a defined plan
  • Design and Develop V&V test designs and procedures that build confidence in the software and the device
  • Coordinate and execute the V&V testing process using productivity tools for configuration management and issue tracking;

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


Examples of our Work


Medical Device Verification & Validation Capabilities

Service Offerings
Hands-on Project Participation
  • Turn-key Verification and Validation Services
  • Validation Remediation
  • Validation and SQA Compliance Remediation
  • Reverse Engineering & Remedial Test Design
  • Validation and Turnarounds
Verification/Validation/Test Project Management
Training
  • AAMI Certified Trainers and Courses
Coaching
Expert Witness Services
Verification & Validation Testing
Test Fixture Design
Unit Level (aka White Box) Testing
Integration Testing
System Level (aka Black Box or Functional) Testing
Regression Test Analysis
Test Automation
Final Validation Reports
Non-Device Software Validation - 820.70(i)
V&V of Added Features
Corrections to address CAPA
Design Control Documentation
V&V Planning (including unit, integration system)
Configuration Management Planning
Issue Management Planning
Risk Management Plan
Risk Analysis
Risk Management Report
V&V Reports
V&V Test Artifacts
Design Verification Reviews
Trace Matrix Tables
Documentation Outputs
Validation Contributions to Design File History
Specification Documents
Test Documents
  • Protocols
  • Test Designs
  • Test Cases
  • Test Procedures
Code Review / Unit Test
See Development Capabilities for List
RTOS (Real Time Operating Systems)
See Development Capabilities for List
Communication Protocols
Verification of Communications Protocols
Specializing in Validation of Inter-processor communication protocols
Defect & Issue Management Software
TestTrack
Bugzilla
Redmine
JIRA
Requirements Management Software
IBM Rational DOORS
Siemens Teamcenter
Seapine TestTrack RM
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)
45 CFR Parts 160 and 164 HIPPA

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