Sunstone Pilot™ On-site On-demand 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 methods. 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 classes are delivered when and where you want them—at your offices, at our center locations, or at a location of your choice.

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.

Our goal is to equip your organization with the tools and knowledge for better medical device development.  We are also committed to helping individuals at your company grow their careers and improve their professional knowledge. 

Training Course Descriptions

Fundamentals of Medical Device Design Controls

This continually updated class covers design control processes for medical device development in accordance with current FDA regulations and international standards. It describes the basic concepts of design controls and provides practical 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 (including Q&A session):  $1950 (per group of up to 20 students) 

Interactive version with hands-on exercises:  $2950 (per group of up to 20 students)

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

Software presents additional challenges for product development teams. 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 practical 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 (including Q&A session):  $1950 (per group of up to 20 students)

Interactive version with hands-on exercises:  $2950 (per group of up to 20 students)

Group Classes (for product teams or departments)DurationPrice*
Lunch & Learn: Design Control Failures0.75 hrFree
Lunch & Learn: Risk Management Failures0.75 hrFree
Fundamentals of Design Controls – with Q&A1.5 hr$1950
Fundamentals of Software Design Controls – with Q&A1.5 hr$1950
Fundamentals of Design Controls – Interactive with hands-on exercises3.0 hr$2950
Fundamentals of Software Design Controls – Interactive with hands-on exercises3.0 hr$2950
Optimizing Design Controls (custom)
Training completely customized to your company’s quality system procedures and products; learn how to optimize compliance at all stages of new product developmentCustomCustom

*Price is for training a group of up to 20 people

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

Additional Training Resources

For more detailed and specialized training, consider these multi-day training classes:

Design controls class by AAMI (Arlington, VA; 3 days; $2600 per student)
Agile Medical Software Development class by Agile Quality Systems and AAMI (Arlington, VA; 2 days; $2435 per student)