White Paper

Innovation No Longer Means Increased Costs

Durable plastic devices have been used for more than 100 years, especially since injection molding offered faster manufacturing processes, but providing an efficiently made, durable plastic is no longer enough for most companies.Download now to learn more.

Top Five Design Mistakes to Avoid When Specifying Stainless Steel Tubing

Sometimes when people order tubing, they specify the dimensions without considering the tubing’s fit with other components. Components must have clearance between them in order for them to fit together.

Establishing Bioburden Alert and Action Levels

It is the intent of this article to provide insights to the many facets involved in establishing bioburden alert and action levels in a variety of situations. These practices are not intended to be rigidly applied, as different situations might necessitate a different approach than those provided.

Successful Medical Device Cleaning Validation: What You Need to Know

This comprehensive overview of medical device cleaning and reprocessing validation highlights what you need to know, where to start, and with whom to partner.

Sterilization and Biocompatibility of 3D-printed Orthopedic Devices

Orthopedic medical devices fabricated using 3D-printing methods, also known as additive manufacturing, are gaining attention and popularity due to their potential for enhanced biocompatibility, customizability, and cost effectiveness.

ISO 80369-7: Changing the Standard for Luer Connectors

ISO has formally published 80369 Part 7, the long-awaited replacement to ISO 594, the standard governing dimensions and performance requirements of Luer connectors. The publication caps a monumental change in the fundamental thinking surrounding devices that transfer liquids and gases in healthcare settings.

THE ULTIMATE GUIDE TO Exemption Certificates for Sales Tax Compliance

Achieving sales tax compliance in today’s complex environment is no easy feat. There are changing rates to calculate, evolving requirements to monitor and a wide array of exemption certificates to manage. Companies must handle every step correctly, and each one is riddled with potential pitfalls. To achieve and maintain sales compliance, it’s critically important to understand how exemption certificates work, when to collect them and what steps to take so they remain valid and up to date.

Warning: Everything You Know About Medical Design is Wrong

This medical device whitepaper proves when quality is embedded in the product design and development cycle — coupled with modern risk management tools — supply chain oversights, employee missteps and product design errors can be dramatically reduced.

Reduce Regulatory Delays by Formalizing Design Control Process

The medical device industry stands at the crossroads between innovation and increased regulation. The lack of formal Design History Files (DHF) and Device Master Records (DMR) is one of the most important reasons for issuing non-conformance directives to medical device makers. Luckily, effective Product Lifecycle Management (PLM) solutions, can help to facilitate proper management of quality documentation, and ease the pains of the regulatory approval process while accelerating time to market.

Glass-Sealed Connectors Help Increase the Longevity and Reliability of Medical Devices

The electronics inside modern medical appliances need protection from the intense conditions in the autoclave. One of the most important components in this process is the connector, which makes electrical and data connections between device sections. Implementation of high-quality connectors using the right materials is crucial. Inferior components can weaken the protection of the device's electronics. Learn more!

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