Group of people

Custom In-House Training

Training for Medical Device Manufacturers & Suppliers

Customized in-house training from Winovia offers substantial benefits and savings to medical device manufacturing companies who are looking to develop their workforce knowledge and skills. Winovia can tailor courses to each company’s unique products, and employees are able to talk candidly about sensitive and proprietary information. In addition, in-house training is cost effective, saving costs of travel, lodging and enrollment fees for open-enrollment courses.

Risk Management — Topics include:

  • Regulatory Requirements for Risk Management in Medical Devices
  • Leading remediation projects; functioning as the acting or interim Director of Quality Systems
  • ISO 14971:2019 overview
  • Software Risk Analysis
  • Steps for Conducting Risk Analysis for Medical Devices
  • Fault Tree Analysis
  • Overall Residual Risk
  • Risk-based decision making
  • Principles and Intent of Risk Management
  • Leading remediation projects; functioning as the acting or interim Director of Quality Systems
  • Usability Engineering and Human Factors Engineering
  • Risk Acceptability Criteria and Residual Risk
  • Failure Mode and Effects Analysis
  • Leading remediation projects; functioning as the acting or interim Director of Quality Systems
  • Production and Post-production activities
  • Closed-loop Risk Management Process

Process Validation — Topics include:

  • Regulatory Requirements for Process Validation
  • Relationship of Process Validation to Design, Risk Management, Supplier Controls
  • Test Method Validation
  • Site Master Validation Plans and Validation Plans
  • Engineering Studies and Design of Experiments
  • Installation Qualification (IQ); Software Validation
  • Operational Qualification (OQ)
  • Qualification (PQ)
  • Process Controls, process monitoring
  • Principles and Intent of Process Validation
  • Statistical Techniques and Sampling Plans
  • Process Verification versus Process Validation
  • Validation Life Cycle and Revalidation

Design Controls — Topics include:

  • Regulatory Requirements for Design Controls
  • Principles and Intent of Design Controls
  • Defining User Needs and Intended Use
  • Design and Development and Design Outputs
  • Differences between and principles of Design Verification and Design Validation
  • Design Changes and Change Control
  • Product Life-Cycle Management
  • Linkage of Design Control and Risk Management
  • Determining Design Inputs
  • Identifying Essential Design Outputs
  • Effective Design Transfer Processes
  • Customer feedback and Continuous Design Improvement

In-House Training Contact Form

Start the discussion to see if your organization would benefit from custom in-house training.

In-House Training

I’m interested in these training topics (Check all that apply)

Stay Connected

For occasional updates on trainings, conferences, and news articles, join our Email List.
We will never share your information.

Email List