Consulting, Mentoring, and Training Services
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Intertech Engineering Associates, Inc. partners with medical device companies in many ways to help them meet their most pressing engineering, quality, regulatory and project management challenges. In addition to hands-on contributions to our clients’ development and validation projects, Intertech often plays the role of consultant, mentor, or coach to critique, educate, and guide our clients’ efforts. Often these roles are not at the project level, but at the quality system level that applies to all future development efforts within the client company.
How do you know if these services will benefit you and your company?
A consultative relationship is effective for clients for many different reasons.
- Companies working through their first medical device development project.
- Companies who have had regulatory compliance problems with Design Controls in the past and want remedial and/or ongoing help to avoid future problems.
- Companies that have engineering, production or quality employees that are not from the regulated medical device industry, and who are having difficulty adapting to the regulated environment.
- Companies who have “mature” quality systems but sense that productivity has been sacrificed.
- Companies with very detailed quality processes and procedures that experience recalls months after release of devices.
Whatever your reason, Intertech is here to help you to find the deficiencies in your project or quality system, teach you the fundamentals of our regulated industry, help you identify and address project level and quality system level problems, and as the project progresses, guide you to successful completion in a cost effective manner. Intertech’s medical device experienced engineering team can even provide hands-on contributions to development or verification/validation artifacts as described elsewhere on our website.CONSULTING – FINDING THE PROBLEMS, RECOMMENDING SOLUTIONS
Our consulting projects with clients are typical limited term engagements that are focused at either specific projects, or at the client’s quality system in general. Activities include:
- “friendly” audits of device history file (DHF) documents for compliance and traceability to the quality system (project level consulting)
- “friendly” audits of quality system documentation for compliance and traceability to regulations, guidance, and industry standards (quality system level consulting)
- Reviewing quality system documents for opportunities to streamline processes and procedures to increase productivity without sacrificing quality or safety.
- Reviewing project DHF documents for opportunities to streamline implementation of existing quality system processes and procedures.
MENTORING – TRAINING CLIENT’S TEAM IN THE FUNDAMENTALS
Incorporating change often requires more than just dropping a binder full of new procedures on the desk of a team member. Sometimes, formal training and ongoing coaching are important parts of successful change. Intertech offers public off-site training in collaboration with the Associations for the Advancement of Medical Instrumentation (AAMI), or we can offer private on-site and off-site training in the targeted areas of our expertise:
- Developing Compliant Medical Device Software
- Validation of Medical Device Software
- Validation of Production and Quality System (i.e. non-device) Software
- Risk Management
- Training in Client’s Newly Revised Quality System Processes and Procedures
Training programs can be customized to fit your company needs and the training can run from 4-hour seminars to multi-day workshops.
David Vogel, Ph.D., president of Intertech Engineering, wrote the first book (Medical Device Software: Verification, Validation and Compliance) specifically geared to help medical device software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software. Dr. Vogel and others from Intertech have trained thousands in the medical device industry on these topics at public and private multi-day workshops, and at public tradeshows (MD&M, MEDTEC) and industry meetings (Medical Device Summit, IQPC Best Practices in Medical Device Software, Medical Device Quality Congress, FDANews Webinars, and the newly formed Institute for Medical Device Development (IMDD).
Intertech has collaborated with AAMI to develop the AAMI Software Validation 3 day workshop based Dr. Vogel’s book. (Use of AAMI courseware must be coordinated with AAMI in advance).COACHING – KEEPING THE TEAM ON-TRACK
Coaching involves periodic contact with the client to review their progress in incorporating change, or in adapting to the regulated medical device industry. Coaching relationships are usually contracted as retainer relationships that book a certain amount of time per week or month from Intertech. Coaching can be particularly cost effective to:
- Address questions and issues that come up while incorporating change before misunderstandings get “baked into” the project documentation.
- Keep the team aligned with the intent of the quality system to prevent misunderstandings or bad habits from becoming to engrained.
- Identify any issues with the changes to the quality system, development, or validation procedures that need a mid-course correction.
- Recommend best practice examples of complying with the newly incorporated changes.