Newsletter | January 16, 2024

01.16.24 -- Key Considerations In "Intended Use" And "Indications For Use" Statements For Medical Devices


Key Considerations In "Intended Use" And "Indications For Use" Statements For Medical Devices

You are familiar with the terms “intended use” and “indications for use.” But not everyone understands exactly what they mean, how they are different, and how they are used. It's critical for the successful development, regulatory approval, and reimbursement of your device.

Midline Catheters Show Fastest Growth Rate In Vascular Access: A Global Market Analysis

In many situations, midline catheters present a superior choice compared to short peripheral catheters, which are suitable for brief indwelling periods, and PICCs, which carry a higher risk of central line-associated bloodstream infection (CLABSI) and are more complex to insert. Let's examine new market research.


The Benefits Of Aqueous Critical Cleaning In Medical Device Manufacturing

The use of aqueous cleaning in medical device manufacturing can provide numerous benefits in terms of efficacy, minimal surface contact and reduced residue potential, and easier cleaning validation.

Fixed Volume Pumps For PCR Testing

Molecular diagnostics is increasingly used for the rapid detection and identification of existing and emerging pathogens. The need for rapid results has required testing to move to smaller, more widespread, and often temporary point of care (POC) locations.

Bringing The Advantages Of Liquid Crystal Polymers To Wearable Injectors

When it comes to the field of wearable injectors, an advanced LCP polymer provides a host of benefits over traditional thermoplastics — ensuring you are choosing the right polymer for your process.

Micromold Tool Transfers

Unprecedented demand for tool transfers is top of mind for R&D engineers, technical sourcing leads, and supplier engineers. With that, micromold tool transfers are a major consideration.


The Secret To Medical Device Development Success: A Mindset For Continuous Learning

Can Aptamers In Wearable Sensors Mean A Revolution In Healthcare?

How To Make The FDA Happy: 7 Medtech Design Pro Tips For Combination Products

Introduction To The New ASTM E3418, Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices

Understanding The FDA's New Medical Device Cybersecurity Guidelines


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