Health, Medicine, & Biotechnology

Planning for Implementation of the European Union Medical Devices Regulations – Are You Prepared?

The Medical Device and In Vitro Medical Device Regulations represent the most significant change to the European legislation for medical devices for nearly 20 years. Understanding the requirements is key to your ability to develop an implementation plan to ensure continuing regulatory compliance and provide the EU market with safe medical devices.A new white paper, “Planning for Implementation of the European Union Medical Devices Regulations: Are You Prepared?” focuses on the practical aspects of implementation. It discusses decisions that need to be made and includes questions to ask about your organization’s preparedness to comply with the new requirements.Download this new white paper to learn how to address: Activities and requirements for manufacturers, authorized representatives, importers, and distributors Existing products and their technical documentation, including clinical evidence Products in the development pipeline Responsibilities of the person handling regulatory compliance, ISO 13485:2016 certification, and lifecycle management Content and maintenance of technical documentation Unique device identification, implant cards, and labelling changes PMS plans, periodic safety update reports (PSURs) or post-market surveillance reports, and post-market clinical follow-up (PMCF)

Posted in: White Papers, Manufacturing & Prototyping, Bio-Medical, FDA Compliance/Regulatory Affairs, Medical


Ensuring the Reliability of Disposable Syringes with Light-Cure Adhesives

Perhaps one of the most challenging aspects of disposable medical syringe production involves permanently and safely attaching the stainless steel cannula to the plastic hub. This joint is critical to the safety of syringes found on hypodermic and biopsy needles, syringes, winged infusion sets, blood lancets, and a variety of other devices. In all these applications, poor hub-to-cannula assembly could result in leakage of bodily fluids and medication or catastrophic device failure, situations that could be dangerous to the patient and the medical professional. Mechanical failure of a syringe can cause painful insertion or extraction, seal failure during use, cancellation of a procedure, or other unsafe complications.

Posted in: White Papers, White Papers, Bio-Medical, Medical


The Simple Guide to a Life Science Recall

Recalls erode consumer trust, brand integrity, company image and longevity. Since there is a lengthy process that follows the event of a recall, here is how a GMP Compliance Management System can help to make the process as efficient, painless and quick as possible.Download this paper to learn about: Complaint Handling Product Returns Document Control Recall Evaluation Corrective Action Centralized Reporting

Posted in: White Papers, White Papers, Bio-Medical, Medical


Life Sciences Guidebook: Best Practices for FDA Compliance Solutions

In a market where high-demand causes organizations to seek software systems that will fit into their complex business infrastructure, the pressure to find the right system often causes angst to many. Learn some of the key elements to spotting a good FDA Compliance solution, techniques for achieving GMP Compliance, and how to ensure that Quality and Compliance are met in the Life Science industry.

Posted in: White Papers, White Papers, FDA Compliance/Regulatory Affairs, Software


Evaluation of Platelet Aggregation on Commonly-Used Blood-Contacting Medical Polymers

The blood compatibility of polymers used for medical devices which facilitate the movement or storage of blood is critical, particularly in devices whose applications where device-contacting blood will be re-introduced into a patient (dialyzer housings, storage vessels, IV components, etc.). Standard biocompatibility testing conducted in accordance with the ISO 10993 series of standards for these materials includes various tests for hemocompatibility1, including platelet interactions, but direct microscopic examination of platelet adhesion and activation is less common. This white paper presents the results of a scanning electron microscopic (SEM) examination of human platelet adhesion on polymeric materials, which shows that CYROLITE® materials may be less likely to aggregate and activate platelets than some other commonly-used blood-contacting materials.

Posted in: MDB, White Papers, White Papers, Bio-Medical, Medical


How the Laser, Optic, & Photonic Industries Benefit from Electropolishing

Improve precision and cleanliness with an enhanced surface finish. Like other industries that utilize electropolishing to finish metal components, there are many benefits associated with electropolishing metal components used in photonics, optics or laser applications.

Posted in: White Papers, Coatings & Adhesives, Materials, Medical, Optics, Photonics


5 Ways the Automated Compliance Management System Provides Value for Your Organization

When looking for a Compliance Management system that is ideal for your organization, there is a lot to take into consideration - with so many options out there it becomes difficult to choose the system that will provide the most value.

Posted in: MDB, White Papers, White Papers, Medical


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