Manufacturing & Packaging Articles
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Toxicological Risk Assessment Of Medical Devices: An Overview
4/19/2018
The FDA requires toxicological risk assessments performed for most medical device submissions founded on the notion that if all of the constituents of a medical device are known, then the safety of the device can be assessed based on the toxicology of those constituents.
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A Balanced Distribution Of Risk: Is Your CDMO Relationship Set Up For Success?
4/2/2018
Beware of any scenario where the word “partnership” is used only to obtain a better price and/or more aggressive terms, as this is the origin of failed relationships. A true partnership should define terms that balance the risk and reward for each party.
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Reducing The Life Cycle Cost Of Validation (Part 1): Appropriate Material Selection And Part Design
3/29/2018
Several key areas with specific criteria are critical to IQ/OQ/PQ process, yet often overlooked or underestimated. In this segment of the series, we will review some of those important details you should consider during material selection and part design.
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The Role Of Packaging In Supply Chain Management
2/14/2018
In order to achieve a successful supply chain management, packaging systems have to be connected with aspects of marketing, logistics, productions, and the environment.
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Assuring Reliability In Medical Device Manufacturing Using Automation And A Digital Factory
1/31/2018
.A fail-safe, fast response strategy for manufacturing reliable medical electronics in a controlled, data-rich, and cost-efficient environment.
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Why Predictability Matters In High-End PCB Manufacturing
1/3/2018
Predictability is essential for PCB manufacturing. Without it, a product’s reliability cannot be assured. Conventional approaches to predictability often fall short. Inspection, for example, only reveals superficial flaws. Micro sectioning is destructive in nature and inadequate for complex PCBs with thousands of vias.
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Giant Step Forward For Neural Bypass Technology
9/27/2017
How recent accomplishments are taking science a step closer to realistically fixing paralysis.
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OEMs: Do You Trust Your Medical Device Supplier’s Quality?
8/1/2017
As an OEM, it is your responsibility to ensure the parts supplied to you are compliant with ISO regulations. Ideally, your supplier’s quality systems are strong enough to identify risks, prevent defects, and to catch defects quickly if they do occur. This requires a robust quality management system.
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The Coming Wave Of Dual-Chamber Systems For Drug Delivery
8/1/2017
Selecting and validating the best dual-chamber design option for the delivery of a given pharmaceutical.
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Managing The Unpredictability Of The Product Development Process
8/1/2017
How development teams need to engage in the holistic, programmatic risk management necessary for a predictable development program.