FEATURED EDITORIAL

Teamwork iStock-1279995279 How To Enable Your Quality Risk Management Lifecycle

The topics covered in this article represent some of the common risk management pain points and mechanisms to overcome these challenges, focusing on the foundation of quality risk management (QRM). This includes using consistent terminology, determining risk strategy, implementing QRM, and the advantages of early implementation.

  • The expanding use of extended reality (XR) in medical applications presents a number of unique opportunities and challenges. Due to the extensive reliance on software and networked data, cybersecurity risks must be addressed during the design, development, and use of XR devices. And, of course, compliance with all regulations concerning privacy and control of PII is essential. 

  • Say “start-up” in the medical device community and the conversation can move quickly to funding. Who will invest? How much? How long will it take? Here are five tips to help a medical device start-up be more interesting, more attractive, more investable – and less risky – to potential funders.

  • While face-to-face access is once again possible, and access continues to improve, it has not, and will not, return to 100% of pre-pandemic levels. Medical device organizations must evolve their commercial strategies to be more flexible, resilient, and nimble. Hierarchical decision-making and slow time-to-market strategies should be replaced by operational agility as well as a “test-and-learn” culture that demands cross-collaboration and values data-driven solutions.

INDUSTRY INSIGHTS

  • ISO Standards: Turning Hopes Into True Quality Objectives

    Aligning your company’s quality management practices with the applicable quality principles found in the ISO 9000 family of standards is a proven approach for turning aspirations into actual quality objectives. Here, we review key quality principles addressed in ISO 9001 and examples of ways the standard can be leveraged to reach the kinds of objectives your organization may be looking to achieve.

FDA Inspection Preparation: SOPs, Process Maps, And Gap Analysis

Process mapping and gap analysis can help manufacturers not only show the FDA that an organization is compliant with regulatory expectations, but also help demonstrate that standard operating procedures (SOPs) are correct and that employees understand them.

Simplifying Commercial Software Validation In Medtech Manufacturing

Commercial off-the-shelf (COTS) software has dramatically enhanced medical device manufacturers’ ability to accelerate production, integrate processes, and manage quality effectively. Learn more about FDA guidelines on the horizon for COTS software and tips on how to approach validation until such guidelines are finalized.

How Electronic Batch Records And Device History Records Close The Digital Manufacturing Gap

We need to remedy the fact that the vast majority of life science manufacturers are still on paper. Digitizing the paper-based production record process can close this gap by creating productive connections between people, processes, and systems throughout the manufacturing process and across the entire enterprise for a holistic view of production data.

Simplifying The Transition From 5G Operations At Sub-6GHz To mmWave

There are three key differences between sub-6 GHz and mmWave operations. There are also a variety of different RF design challenges at mmWave largely because as frequency increases, wavelength decreases.

SOLUTIONS

The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.

Caplugs has been a global leader in plastic molding with six different molding processes and thousands of material options. The in-house team of engineers works with customers throughout their comprehensive process to design a unique solution process from creating concepts and rapid prototyping to packaging and inventory management.

As the global life expectancy continues to get longer, the demand for electronic medical implantable devices is growing. Knowles offers a variety of capacitor solutions for the medical implant industry.

Quick Time To Market, Significantly Lower Risk

Daikyo Crystal Zenith® Luer Lock syringes are designed to fit a variety of standard drug delivery devices, and compared to glass they offer unprecedented strength, durability, and protection.

Proto Labs is proud to introduce PolyJet technology to their 3D printing capabilities. PolyJet technology is used to provide designers and engineers with the ability to manufacture elastomeric and overmolded prototypes without investing in tooling. This technology can create 3D-printed parts comprising both elastomeric and rigid materials, as well as multiple colors.

MTD Micromolding is solely committed to providing the highest quality micromolding services of advanced medical products. MTD offers their innovative skills in exploring and producing very small, delicate, and intricate components required for advanced medical applications and products such as specialized surgeries, bioabsorbable devices, and implant devices. With a constant demand for newer, smaller, never-before-seen micro medical devices, MTD is also prepared to assist their strategic partners in the development of new solutions.

FEATURED SUPPLIERS

Packaging Technologies & Inspection (PTI) is a leading manufacturer of inspection technologies for the pharmaceutical industry that are non-destructive, non-invasive and require no sample preparation.

At Medbio we contribute our knowledge, expertise, and the latest technology to provide products that improve the quality of life.

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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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