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I'm Rick Bollinger, a management consultant with decades of project management experience. A number of those years I was privileged to work in the medical device manufacturing industry. So, now I’m working to help…
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My solutions will help you sleep at night. Even if you don't often get Official mail from the FDA. You won't worry about device defects sitting on your loading dock, or compliance errors waiting for your next inspection. You'll be doing all within your power to prevent them. Here's the deals:
Vote on requirements.
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❶ Give me your email address and I'll send you an Aggressive Risk Management Method PDF for FREE. It combines FMEA and Fault Tree Analysis (FTA) to iteratively and incrementally lower failure mode probabilities.
❷ Let me interview you and I'll help you implement the method for FREE.
❸ Let me interview you and you'll get to VOTE on deferred requirements and otherwise see your unique needs addressed in the new product.
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That's what we're building.
Social network technology software for the manufacture of safe, effective, and secure medical devices.
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Your path to justice.
1. Chances of an FDA recall never go to zero.
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2% of device manufacturers have been hit with FDA recalls. Meaning the other 98% may be one defect away from their first recall.
16% of all companies have no recalls but have received citations. Does this predispose them to recalls? Does smoke mean there's a fire? 82% have no history of recalls or FDA 483 citations, but still need to sleep. Request the Aggressive Risk Management method white-paper PDF below. 
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2. Own your tomorrow. Starting today.
Never zero, you can still get close. Make recall probabilities as tiny as you want. Never be surprised by a defect. There is opportunity here. You don't have to spend a lot of money. Just try something new. Something different. The best day to start preventing tomorrow's recalls is TODAY.
Click the interview/DEMO button below now.
Click the interview/DEMO button below now.
3. Apply a new method of risk management.
I have developed an Aggressive Risk Management method that will iteratively and incrementally reduce failure mode probabilities. Request the PDF for FREE. It combines FMEA and Fault Tree Analysis (FTA). The white-paper also suggests some practices to turbo-charge your risk management. Let's rescue the industry from its Recall Epidemic.
Human lives are in the balance. Request Aggressive Risk Management pdf below.
Human lives are in the balance. Request Aggressive Risk Management pdf below.
4. Interview/DEMO with me.
Learn about the method and the role it can play in your organization. Learn to turbo-charge risk management practices and facilitate them with software. Prevent errors of omission and commission. You don't owe me anything. You don't owe the industry anything. But, this is a big opportunity for leaders to demonstrate their potential.
Help maintain the stature of our industry that does so much for humanity.
Help maintain the stature of our industry that does so much for humanity.
Join our cast party!
Interview me and I will support your implementation of the method into your processes for free (+ expenses). It includes a complete presentation on the method. The interview/DEMO and consulting can be done over the Internet or on-site and in-person. Let's choose how much of each to match your needs. Also, the interview gets you a token which is your ticket to the cast party near the end. Yahoo!
See below how many tokens/tickets are still available.
See below how many tokens/tickets are still available.
5. Champion new solutions to recalls and citations.
Do all within your power.
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Learning about new methods and software is interesting. But, the software is not finished yet. It needs final requirements. It needs people in your position to help define it. People with imagination. Not a lot of your time is needed. Just a dash of vision.
Be a champion and help bring solutions into the world. Take a few minutes out of a day to help stop the 2% from producing recalls.
Help stop the 16% from producing citations. Request Aggressive Risk Management pdf below. |
A Fair Deal for the 1st 100: software meeting your exact needs.
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Be among the 100 to Interview/DEMO. Then help define, design or develop the software. See the DEMO. With a little imagination and vision you can realize the power it will bring to your everyday work. This offer to prescribe requirements is limited to the first 100 who interview. See at right how many tokens/tickets are still available now.
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TOKENS
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Check the deferred requirements list below to see if anything looks interesting to you after you interview. Contact me for clarification. There's lots that can be done when everything's connected.
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Complaint Handling Sub-system
Corrective and Preventive Actions Integrated Medical Device Reporting Digital QMS and SOP Procedures Add Digital Procedure to Project Google Language Translation Online Speech Recognition |
Internal FMEA & FTA Analysis
Issue and Task Acceptance Complaint Predictive AI Medical Device Report AI Risk Management AI Lesson Learned generation Task and Issue Email Update |
Agenda SQL
Risk Vault User Types Permissions Issue Escalation Preferred Devices Complex organizations |
VOTE to make sure that your specific needs are addressed. Don't miss out.
6. Traction for funding and development.
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Building the software needs funding from angel investors and venture capitalists. Your power is to express your desire for such a solution as this. Also, grant us your vision of tomorrow. When a critical mass of volunteers like you have indicated their demand, we will have evidence of traction. This we can take to investors in the medical device space to convince them to invest in our future.
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Familiarity and Ease of Introduction
The software was also designed to be familiar to users. They will see, and manage, projects, team members, issues, risks and tasks. And, these would show up in status reports and meeting documents. All these objects would have discussion threads. Changes and team member comments would be captured in thread logs and made into compliance evidence for saving into history records and files. Automatically. Don't believe it? Click the interview/DEMO button below now.
Price and Scale
The software was designed for medium-sized medical device manufacturers. However, it has features, like communities, procedures and sub-projects that scale up for larger organizations. It will be priced at much less than the $200 per month per seat charged by many big QMS vendors. The sofware will be priced for companies to help them grow without too much pain. Interview to get into the discussion about price.
Click the interview/DEMO button just below now.
Click the interview/DEMO button just below now.
