Innovation, efficiency, and safety can coexist when a team uses effective design controls. In this article, I apply modern design controls to a product I co-invented and commercialized in 2004 using lessons learned in 15 years.
I describe that product in
another article. This article helps you learn from my mistakes.
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The European MDR: learn from my mistakes
/in EU-MDR, Medical Devices /by jasonpartinThis article is to help you learn the MDR using a product I co-invented and commercialized in 2004, demonstrating how to apply modern MDR regulations. I describe that product in another article. This article helps you learn from my mistakes.
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Design Control: learn from my mistakes
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Risk Management: learn from my mistakes
/in Medical Devices, Risk Management /by jasonpartinI describe that product in another article. This article helps you learn from my mistakes.
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You get what you give in Varanasi India
/in Uncategorized /by jasonpartinThe Lonely Planet guide to India, the gold-standard of travel guides, a bible for budget backpackers, and usually a kind voice encouraging you to travel without judgement, said this about Varanasi India:
Varanasi tested my patience, humor, and immune system more than anywhere in the world, yet remains one of my favorite memories of a trip across Nepal and India.
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Mindful meditation for pain relief
/in Meditation, Uncategorized /by jasonpartinMeditation and mindfulness reduce suffering from pain. The United States Veterans Administration advocates mindful awareness, a process each person must follow until finding what works for their unique situation. Many books and online resources are available to help your process; here’s what worked for me, I hope it helps you. Read more
Meditate on the Buddha’s final words
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Medical Devices: learn from my mistakes
/in Medical Devices /by jasonpartinThat sounds like a success, but years later I learned that our product caused pain and suffering for some patients and added useless healthcare costs to everyone.
In this article you can choose your adventure, choosing which you’d like to see addressed after 15 more years of experience in:
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Risk Control & Risk-Benefit
/in EU-MDR, Medical Devices, Risk Management /by jasonpartinThis article explains Risk / Benefit analysis and Risk Control methods using performances of Harry “The Hat” Anderson, a comedian, actor, and magician famous for visual humor.
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Make state of the art medical devices
/in Design and Manufacturing, EU-MDR, Medical Devices, Risk Management /by jasonpartinThe new European Union Medical Device Regulation will protect patient safety by requiring healthcare companies to make products that are “state of the art,” a term that’s easily misunderstood. This law is best explained with an example from cars, comparing today’s state of the art with to the 1980’s television series Knight Rider, where David Hasselhoff fought crime in a talking, self-driving car.
Take this quiz to see if you’re ready for MDSAP
/in Medical Devices /by jasonpartinBy January 2019, the Canadian government will require all companies selling medical devices in Canada to be certified under the Medical Device Single Audit Program (MDSAP). If you’re familiar with MDSAP, this article quizzes your knowledge of key concepts. If it’s new to you, read how to prepare for MDSAP.
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