Newsletter | November 30, 2023

11.30.23 -- SaMD PCCP Implementation Beyond AI/ML: Considerations & Challenges

FEATURED EDITORIAL

SaMD PCCP Implementation Beyond AI/ML: Considerations And Challenges

This is the third and final installment in a three-part article series on post-market change controls and implementing a predetermined change control plan (PCCP) for Class II software as a medical device (SaMD) products beyond artificial intelligence/machine learning (AI/ML).

INDUSTRY INSIGHTS

Critical Cleaning For 3D Printing In The Life Sciences

Here, we focus on the critical cleaning of hard surfaces utilized in 3D printing processes across industries, such as extruded plastics, photosensitive substrates, metals, and metal alloys.

Micro Injection Molding For Thin Wall Drug Delivery Components

There are many types of challenges that can cause a high-precision micro medical molding project to fail, including delays in validation, achieving multicavity capabilities, and product launch issues. This case study presents a customer that encountered all of these challenges at once and looked to MTD Micro Molding to complete the product validation and preproduction runs that a competitor could not complete for them.

Meeting The Unique Design Requirements For Leadless Pacemaker Electrical Components

In the last decade, innovations in technology have led to the introduction of the leadless pacemaker, which is about 1/10th the size of a traditional pacemaker, or about the size of a vitamin.

Cultural Audits: What Are They And Why Are They Essential?

The medical device industry is familiar with quality audits, but it is less familiar with the benefits of having a cultural audit to assess the competence, dedication, and passion that each party brings to the table.

Thin-Wall Polyester Heat Shrink Tubing In Medical Device Manufacturing

Nordson MEDICAL has developed a proprietary process to manufacture thin-wall heat shrink tubing from polyester (specifically, polyethylene terephthalate, or PET) that exhibits extraordinary tensile strength, even with walls as thin as 0.00015”.

Selecting The Best Pinch Valve For Your Application

There are two primary types of pinch valves used in the medical and scientific industries: external and internal. Each has benefits and drawbacks, depending upon its end use. The core functionality of a pinch valve is a flexible flow path element that is compressed by an external plunger or pinch block.

Incorporating Pressure Sensor Technology Into Catheters

Explore the transformative impact of sensor-enabled catheters on medical procedures and their ability to enhance accuracy and patient care by integrating sensors measuring various body pressures.

ARTICLES YOU MAY HAVE MISSED

A Risk-Based Approach To Assess Particulate Generation For Cardiovascular Devices

The Positive Impact Of The Voluntary U.S. Cyber Trust Mark On IoMT Devices

Deciphering New U.S. Laws Around Predetermined Change Control Plans

FDA Releases Q&A Guidance On Human Factors Engineering For Combination Products

Emerging Trends In Microneedle Drug Delivery Systems

RESOURCES

Characterization And Delivery Of Ultra-Viscous And Non-Newtonian Formulations

Video: The Inside Scoop On Partnering With Donatelle

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