Medical Device Design & Development

INDUSTRY PERSPECTIVES

  • How To Build An Exceptional Medical Device Biocompatibility Program

    In recent years, biocompatibility and compliance with the ISO 10993 family of standards have been an area of significant attention. Demonstrating biocompatibility is an integral part of any device development. This article explains how to integrate a biocompatibility toxicologist into your team and his/her role within the development process.

How Do We Achieve The Promise Of Using Digital Health Measurement? DATAcc Leads The Way

Digital health measures are redefining our understanding of health and disease by changing what we measure and how we measure it. It is the perfect time for the field to build the digital health measurement toolbox with intention – and build it right. The Digital Health Measurement Collaborative Community is a new pre-competitive collaboration dedicated to this, and you can get involved!

5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations

Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.

What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively?

When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?

Digital Health Apps & SaMD: Incorporating Privacy In Design & Development

Some digital health apps are regulated by the FDA and other regulatory bodies, and some are not. But all software as a medical device (SaMD) and digital health apps have a common expectation: privacy. This article delves into the related regulations and how to go about developing your app or SaMD using the 7 principles of privacy by design.

WHITE PAPERS & CASE STUDIES

  • Quality System Metrics That Matter

    Product quality is a top priority in any business because nothing else matters without it. Measuring the impact of quality instantly becomes the No. 1 business imperative when those process inefficiencies begin to negatively affect the bottom line. See how these companies digitized and connected their document management processes to help accelerate the time it takes to get a product to market without jeopardizing regulatory compliance.

Metrics That Matter For Contract Manufacturing

For Contract Development, Manufacturing and Packaging organizations (CDMOs, CMOs and CPOs) improving operational flexibility, increasing capacity, shortening lead times and improving product quality is more important than ever as demand and competition for contract services increases. In these examples we show how moving from a paper to a digital solution these customers were able to eliminate data entry errors, reduce deviations, and improve overall efficiency and productivity.

Getting Executive Backing For A Digital QMS

As someone working in quality, you understand how vital your role is for improving efficiency, achieving quality, and meeting compliance. Your work is critical, and it’s essential to have the right tools do your job well – which means having a digital quality management system (QMS). Most executives cite the high cost of adopting technology as the main reason they reject plans to invest in digital systems. This article offers guidance that will help you quantify and communicate the importance of quality, and how a digital QMS delivers considerable savings.

6 Must-Haves For A Quality Management System (QMS)

The best way to build quality into a product is with an effective, connected quality management system (QMS), which serves as the foundation for long-term regulatory compliance and market success. However, not every QMS has the same capabilities and connectivity. A QMS that isn’t connected to other areas of the enterprise still slows down quality processes and introduces the possibility of more human error. In this article we highlight six features of a QMS system that will help companies realize maximum value for years to come.

Automating Document Control Processes To Comply With FDA And ISO Requirements

Careful handling of the large amounts of documentation required for regulated products is critical for achieving compliance. Furthermore, document control guidelines enforced by the U.S. Food and Drug Administration (FDA) and the standards set by the International Organization for Standardization (ISO) continue to evolve. This means your document control system should be agile and scalable to keep up with the changing regulatory landscape. This article details the FDA guidelines and ISO standards that apply to document control, and it illustrates how digitizing document control processes is essential for ensuring ongoing compliance and future relevance.

DESIGN COMPONENTS & SERVICES

ProMed offers micro molding services for both long-term and short-term implantable medical device components, making parts as small as .002g and shot sizes up to 3g. They have experience with a variety of medical-grade plastic materials (thermoplastics) such as EVA, PSU, PLA, PLGA, PEEK, Filled PEEK, and Ultem. They also work with Polycarbonate, ABS, and Pebax.

Our plastic injection molding process produces custom prototypes and end-use production parts in 15 days or less. We use aluminum molds that offer cost-efficient tooling and accelerated manufacturing cycles, and stock more than 100 different thermoplastic resins.

Ross Optical’s line of micro optics includes achromats, plano convex lenses, and bi-convex lenses. These optical components allow for shorter focal lengths in compact systems and feature diameters from sub-millimeter to 6 mm.

Ross Optical offers a variety of lens types including spheres, aspheres, and micro optics. They’re available from under 1mm to over 150mm in diameter and are ideal for OEM applications in R&D, electronics, semiconductor, pharmaceutical, biomedical, and military markets.

ISO CD 80369-3 was created to define a safe design for an enteral feeding connector. Cardinal Health has helped to develop the ENFit Connection System. This includes a full line of bulk, non-sterile Monoject Purple Oral Syringes featuring the new ENFit connector and a transition connector that allows users to connect to feeding tubes and extension sets with the older design until all components have converted to the new ENFit design.

Flash Lamps - high performance flash and arc lamp applications such as medical and industrial laser pumping, digital and studio photography, warning beacons and strobes, stroboscopic and effect lighting

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