Niall Redmond, Starfish Medical
MEDdesign

Adding the Human Factor to Medical Devices

By Niall Redmond

…down to the subjectivity of comfort and how to design for it. Human Factors and Patient Comfort There are many ways to design for comfort, but first you need to…

…down to the subjectivity of comfort and how to design for it. Human Factors and Patient Comfort There are many ways to design for comfort, but first you need to…

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Build an Effective Global Regulatory Strategy

By Laura Elan, Linda M. Chatwin, Esq, RAC

…significant. These companies often lack internal expertise to conduct appropriate market research or to navigate the regulatory maze. In light of the expanding complexities to bring product to market, the…

…significant. These companies often lack internal expertise to conduct appropriate market research or to navigate the regulatory maze. In light of the expanding complexities to bring product to market, the…

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Latin America, medtech

The State of the Latin American Market for Medical Devices

By Jacob Andra, Rachel Gaines

…sector. The Springboard Approach A common tactic is that of developing a beachhead in a country of relative perceived safety and stability. For example, Mexico has been proved to be…

…sector. The Springboard Approach A common tactic is that of developing a beachhead in a country of relative perceived safety and stability. For example, Mexico has been proved to be…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Response Not Adequate, Ouch!

By Dr. Christopher Joseph Devine

…to ensure their establishments remain in compliance with all applicable quality, regulatory and statutory requirements. Remember, the word compliance is not some neologism (look-it-up). Additionally, compliance is not just another…

…to ensure their establishments remain in compliance with all applicable quality, regulatory and statutory requirements. Remember, the word compliance is not some neologism (look-it-up). Additionally, compliance is not just another…

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Trump’s Gag Order on Federal Agencies Hits HHS, NHS

By MedTech Intelligence Staff

…and speech. However, The New York Times quotes an EPA official, who stated that Trump’s actions are standard of any new administration coming into office. “I don’t think it’s fair…

…and speech. However, The New York Times quotes an EPA official, who stated that Trump’s actions are standard of any new administration coming into office. “I don’t think it’s fair…

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Myanmar

Myanmar’s Medtech on the Rise as Market Opens Up

By Ames Gross

…private hospitals. Newer technologies such as 3-D and 4-D ultrasounds will also significantly improve diagnostic procedures. High quality tests and early disease detection needs will provide Western companies with many…

…private hospitals. Newer technologies such as 3-D and 4-D ultrasounds will also significantly improve diagnostic procedures. High quality tests and early disease detection needs will provide Western companies with many…

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Footsteps

Remediation: What Challenges Do Device Companies Face?

By Maria Fontanazza

…industry or business size—the common denominator is risk. What can companies do to not just reduce risks, but prevent them from occurring in the first place? Download this comprehensive guidebook…

…industry or business size—the common denominator is risk. What can companies do to not just reduce risks, but prevent them from occurring in the first place? Download this comprehensive guidebook…

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FDA Shares the Secret to Stopping Inspections

By Daniel R. Matlis

…Case for Quality movement and demonstrate that your company provides patients access to high quality, safe and effective medical devices. To succeed, your company must share the FDA goal to…

…Case for Quality movement and demonstrate that your company provides patients access to high quality, safe and effective medical devices. To succeed, your company must share the FDA goal to…

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Combination product, drug, device and biologic

Combination Products: FDA Releases Guidance on CGMP Requirements

By MedTech Intelligence Staff

…the rule, explains the role of the FDA centers related to any combination product CGMP matters, and gives hypothetical examples to show companies how to comply with the requirements. https://medtechintelligence.com/feature_article/special-problems-disconnects-combination-products/…

…the rule, explains the role of the FDA centers related to any combination product CGMP matters, and gives hypothetical examples to show companies how to comply with the requirements. https://medtechintelligence.com/feature_article/special-problems-disconnects-combination-products/…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Complaints, Complaints & Complaints: Is Anyone Listening?

By Dr. Christopher Joseph Devine

…dates back to the beginning mankind when Adam complained to Eve about something like eating that damned apple. However, complaints can also be a valuable tool. For example, when customers…

…dates back to the beginning mankind when Adam complained to Eve about something like eating that damned apple. However, complaints can also be a valuable tool. For example, when customers…

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