Price: $2,999.00

Course Number: 500001
Length: 3 Days
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cGMP/QSR and ISO 13485, ISO 14971, IEC 62304, Design Control Training Course

TONEX has helped many medical device and IVD manufacturers implement quality systems that meet the GMP/QSR/ISO 13485 and ISO 14971 and IEC 62304 standards by providing training and consulting. Our team of ISO consultants, trainers, Certified Lead Auditors has implemented quality management systems for companies manufacturing a wide range of medical devices. We will work closely with our customers to determine their business needs, customize a system that meet their needs, and ensure their quality system is implemented on schedule and on budget. All quality management systems we have implemented have met the following standards and regulations:

  • ISO 13485:2003
  • CE Marking for Europe
  • US FDA Good Manufacturing Practice (GMP)
  • Canadian Medical Devices Regulations (CMDR)
  • Japan Pharmaceutical Affairs Law (PAL) and MHLW Ordinance #169
  • ISO 14971
  • IEC 62304



  • Safety, quality and performance of medical devices
  • Quality system requirements for medical device in Europe,Canada,Japan, Australia Regulations
  • Quality System (QS) Regulation
  • Applicability of the QS Regulation
  • Quality management systems for Medical devices
  • Implementation and maintaining a quality management system
  • Elements of a Quality System, Medical Devices
  • System requirements for regulatory purposes
  • Tools to help in fulfilling regulatory and legal requirements
  • Estimate and Evaluate the Associated Risks
  • Control the Risks
  • monitor the effectiveness of the controls
  • A framework to develop a risk management system
  • Identify hazards
  • Estimate and Evaluate Associated Risks
  • Control the risks
  • Monitor the effectiveness of the controls
  • The goal of risk management
  • Internal and Supplier Auditing
  • Facilities, Equipment and Process Validations
  • Installation qualifications
  • Operation qualifications
  • Performance qualifications
  • Software/Hardware Validation
  • Quality System Implementation
  • Quality System Regulation (QSR) - 21 CFR 820
  • Current Good Manufacturing Practice (CGMP)

FDA cGMP/QSR and ISO Certifications for Medical Devices

  • IS9001
  • Quality System Audits - IS13485,USFDA QSR
  • FDA’s Quality System Regulation (QSR) requirements
  • IS13485: 2003
  • Risk management and maintaining effective processes
  • Processes specific tthe safe design, manufacture and distribution of medical devices
  • Tproduce a management system that facilitates compliance tthe requirements of customers
  • IS14971:2007
  • IS14971: 2001, Application of Risk Management for Medical Devices.
  • IS14971 list of steps tbe taken by management in order tfulfill risk-related requirements
  • Accreditation for Management Systems Certification
  • Medical Device Directive 93/42/EEC (MDD)


  • Medical Device Good Manufacturing (GMP) Practices
  • 21 CFR Part 820 - labeling part 801.4 and MDD
  • QSR (Quality Management Systems Requirements)
  • Compiling with the Quality Systems Regulation (QSR)
  • The quality systems for FDA-regulated products (food, drugs, biologics, and devices)
  • Good Manufacturing Practices (cGMP’s)
  • Mandate (management system) demanding quality in the activities that relate tdesigning and producing medical devices
  • Compatible with IS13485 management system
  • Adhering tother legal requirements
  • Sarbanes-Oxley
  • Canadian Medical Devices Conformity Assessment System (CMDCAS)
  • European Union Medical Device Directive (MDD) for the medical devices

IS13485:2003: Quality management systems - Requirements for regulatory purposes

  • Overview of IS13485:2003
  • IS13485:2003 as a quality system standard designed specifically for medical device companies
  • IS13485 standard supplements IS9001
  • IS13485:2003 as IS9001 adapted tmeet the requirements of the medical device industry and it addresses most FDA requirements (21CFR820)
  • Ensuring medical device safety and efficacy rather than enhancing customer satisfaction and continual improvement
  • Product - device and compliance tlegal obligations and requirements
  • Meet and fulfill legal and regulatory requirements
  • Additional requirements for process control, design control, retention of records, accountability, and traceability
  • Planning and the implementation of the quality management system for medical devices
  • Labeling
  • Packaging
  • Process Design
  • Market Approval
  • Manufacturing
  • Encompassing Assessment of Risk
  • Purchasing and Contractor Control
  • Control of Physical Facilities
  • Equipment
  • Design of Processes & Development
  • Design and Production Documentation
  • Effective Design Transfer
  • Production Control
  • Production Records
  • Packaging
  • Traceability
  • Feedback


  • Medical Device Industry - IS14971 - Application of Risk Management
  • International Standard for the application of risk management tmedical devices
  • IS14971 Certification
  • General requirements for risk management
  • Risk management process
  • Management responsibilities
  • Qualification of personnel
  • Risk management plan
  • Risk management file
  • Risk Analysis
  • Risk analysis process
  • Intended use and identification of characteristics related tthe safety of the medical
  • device
  • Identification of hazards
  • Estimation of the risk(s) for each hazardous situation
  • Risk Evaluation
  • Risk Control
  • Risk reduction
  • Risk control option analysis
  • Implementation of risk control measure(s)
  • Residual risk evaluation
  • Risk/benefit analysis
  • Risks arising from risk control measures
  • Completeness of risk control
  • Evaluation of overall residual risk acceptability
  • Risk management report
  • Production and post-production information

IEC 62304:2006

  • Life cycle requirements for medical device software
  • Set of processes, activities, and tasks
  • A common framework for medical device software life cycle processes
  • General Requirements
  • Quality Management System
  • Software safety classification
  • Software development PROCESS
  • Software development planning
  • Software requirements analysis
  • Software Architectural Design
  • Software Risk Management Process

Design Control

  • General Requirements
  • FDA 21 CFR 820.30 and Sub-clause 4.4 of IS9001
  • IS9001:1994 Quality Systems Model for Quality Assurance in Design, Development, Production, Installation, and Servicing
  • Design and Development Planning
  • Design Input
  • Design Output
  • Design Review
  • Design Verification
  • Design Validation
  • Design Transfer
  • Design Changes
  • Design History File (DHF)
  • IS9001:2008 Design Control Procedure
  • Product strategy
  • Design and Development
  • Design Control Implementation
  • Risk Management
  • Establish risk management programs (EN 14971)
  • Risk Analyses
  • Fault Tree Analyses
  • Failure Modes Effects Analyses

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