What We Do ...
EntreMentor, LLC is an organization established to aid entrepreneurial ventures in the commercialization of medical devices.
How We Do It ...
EntreMentor, LLC provides assistance through consultation and contracted services to start-up companies interested in growing their business. When taking a technology or an idea past the research stage and into the market, the process can be overwhelming. EntreMentor has the training and industry experience to navigate the uncertainty and provide rational management solutions.
The Quality Management System under which you develop and manufacture your medical device is absolutely essential to the success of the organization. It establishes procedures for all operations and produces records to demonstrate compliance with the regulation. Some of the key decisions to be made early in a start-up is when to implement the Quality Management System and what form the Quality System should have. The rational solution calls for a balance of control over operations along with inherent simplicity and flexibility to support a dynamic entrepreneurial environment.
EntreMentor has the expertise to provide guidance on when and how to implement a simple, but compliant Quality System. Our members have attended classroom training on the QSR (21 CFR Part 820) and ISO 13485 and worked in Quality Management, gaining first-hand knowledge and expertise in large and small companies.
Let us help you implement a Quality System that makes sense for you.
The development process for medical devices involves a sequence of highly integrated, yet distinct activities that must be executed and documented in accordance with the Design Controls section of the Quality System Regulation (21 CFR Part 820.30) and ISO 13485:2016.
The development can follow a gated process with specific phases that correspond to ongoing activity:
Concept -> Feasibility -> Development -> Design Transfer -> Commercialization
an agile development approach that is more iterative and incremental:
Plan -> Do -> Check -> Act
or a unique process more suited to your specific product.
EntreMentor can help interpret the standards and regulations and work with you to create key deliverables. Specialties include:
- Design History File Creation/Maintenance
- Requirements Definition (User Needs, System Requirements, Usability)
- Risk Management
- Verification & Validation Testing
- 510 (k) Preparation
- Design Transfer & Process Validation
EntreMentor will work with you to optimize your limited resources and reach your goals
Building an efficient organization requires considerations beyond technology and business logistics. Creating the right team with the necessary skills is one of the most important management roles. Managing the flow of information through the organization impacts overall efficiency and effectiveness. Establishing a "culture of quality" in the mindset of all employees is vital for long-term sustainability.
EntreMentor has experience in:
- Organizational Behavior
- Company Culture
- Key Performance Indicators
Let us work with you to achieve operational excellence.
Contact Us ...
Doug Rimatzki, BSEE, MBA is the founder of EntreMentor, LLC, an entrepreneurial entity established to assist companies in the development and commercialization of medical devices through professional mentorship and individual consulting. Doug has 25+ years of experience in regulated industries, particularly in Product Development, Quality Management and Operations. He has been an Entrepreneurial Fellow, a part-time Lecturer / Mentor at the Biomedical Engineering Dept. at the University of Michigan, an Innovation CORPS adviser, and is currently working with several medical device startups. In addition to his professional and educational background, Doug has had formalized training in the QSR, ISO 13485, Product Development (Design Controls, Requirements, etc.), Electrical Safety and Risk Management.