Medical Device Design Control Training

Medical Device Design Control Training 2019-03-02T20:51:06-07:00

Sunstone Pilot™ Training

Sunstone Pilot offers flexible, cost-effective on-site training for medical device design controls, allowing you to train as many or as few employees as you need—from a single team or department to everyone in your organization.

Our goal is to provide teams with a firm foundation in medical device regulation. We will enable your team to be able to effectively translate “regulatory speak” to practical implementation, understand the issues involved with design controls, and integrate compliance into your specific product development. You know what they say--give a man a fish and he eats for a day. Teach a team the fundamentals of regulatory requirements and they can efficiently apply them to every product development project.

With on-site training there are no travel expenses for your employees, and programs are delivered when and where you want them—at your offices, at our center locations or at a location of your choice. With more people where you need them, you’ll increase productivity and keep projects moving.

We also offer free “Lunch & Learn” sessions to review some common mistakes in design controls or risk management.  This is a quick way to raise awareness in a team about pitfalls to avoid in new product development.

There are no travel expenses, and programs are delivered when and where you want them—at your offices, at our center locations or at a location of your choice. With more people where you need them, you’ll increase productivity and keep projects moving.

We are dedicated to helping companies improve their performance in various business functions, including regulatory, product development, go-to-market, compliance, and more. We are also committed to helping individuals at these companies grow their careers and improve their knowledge bases through on-site and classroom courses.

 

Sunstone Pilot™ On-site Training

Fundamentals of Medical Device Design Controls

This continually updated class covers design control processes for medical device development in accordance with current FDA regulations. It describes the basics of design controls and provides recommendations for implementation in new product development. The class includes design planning, product requirements, risk management, usability engineering, V&V testing, design reviews, design transfer to manufacturing, and managing design changes.

Standard class:  $1950

 

Interactive version with hands-on exercises:  $2950

 

Topics will include design control procedures, forms, records, safety/risk management strategies, and strategies for integrating general quality system procedures into design control. Documentation requirements for each design stage will be included as well.

Fundamentals of Medical Device Software Design Controls

This continually updated class covers design control processes for medical device software development in accordance with the IEC 62304 software standard and current FDA regulations. It describes the basics of medical device software development and provides recommendations for implementation in new product development.   The class includes software development life cycle (SDLC), software development plans, software requirements, software risk management, software testing, traceability, software configuration management and release procedures, software defect management, and software maintenance.

 

Standard class:  $1950

 

Interactive version with hands-on exercises:  $2950

 

Group Classes (for product teams or departments) Duration Price*
Lunch & Learn: Design Control Failures 0.75 hr Free
Lunch & Learn: Risk Management Failures 0.75 hr Free
Fundamentals of Design Controls 1.50 hr $1950
Fundamentals of Software Design Controls 1.5 hr $1950
Fundamentals of Design Controls - Interactive 3.0 hr $2950
Fundamentals of Software Design Controls - Interactive 3.0 hr $2950
Optimizing Design Controls (custom)

Training customized to your company’s quality system procedures and products; learn how to optimize compliance at all stages of new product development

Custom Custom

 

*Price does not include cost of facility rental or food and is intended for training of groups of 20 people or less at locations in the SF Bay Area

Included with each training class:

  • Pre-training phone meeting to align on terminology and any special concerns
  • Set of training slides (PDF file) that can be used internally for refresher training and to train new employees
  • DHF Tracker spreadsheet: a list of typical records for medical device development that can be readily customized to your product development project for efficient management of design control deliverables
  • DHF Documentation Map: a visual guide to DHF documentation and the many interdependencies of design controls deliverables