FEATURED EDITORIAL
Unpacking The EU's Mutual Recognition Agreements For Pharma
MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.
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A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”
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Duty Of Disclosure Considerations For Medical Device Patent Applicants With Parallel FDA Submissions
Understanding the crucial overlaps between FDA disclosures and patent law is important for medical device innovators seeking to protect their intellectual property.
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Over 25 years leading global quality and regulatory organizations, I've learned that the most difficult challenges aren't regulatory or technical; they're organizational and cultural.
INDUSTRY INSIGHTS
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PolyPeel™ Peelable Polyester Heat Shrink Tubing
PET heat shrink is a strong barrier for medical devices, but difficult to remove. Peelable polyester heat shrink tubing is designed to overcome PET’s shortcomings.
Resonant circuit performance hinges on capacitor ESR and Q factor. Proper selection boosts efficiency in LLC converters and ensures impedance matching precision in RF systems.
Structural heart innovation demands thinner, stronger materials and scalable manufacturing. Read how material expertise and customization are overcoming industry challenges for better patient outcomes.
Engaging a development partner early provides critical technical and regulatory insight to avoid costly redesigns and establish a clear, achievable path to market.
Bowie-Dick test failures indicate serious sterilization issues. Learn the five most common causes and proven strategies to prevent downtime, compliance risks, and compromised product integrity.
MED DEVICE ONLINE CONTENT COLLECTIONS
Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.
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