How to Gather Clinical Evidence for Combination Products
Susan Alpert, principal of SFA Consulting, explains the role of clinical evidence for combination products and the complexities at play.
Progress of FDA’s Office of Combination Products
What are the challenges faced by OCP?
Does Your Device Play Well with Others?
The comprehensive approach to human factors considers how a product operates alone, interoperability in larger settings, and data management.
Silos and Software in Medical Devices
With the increased complexity of devices, a streamlined approach to managing product development risks and documenting compliance is challenging but perhaps more important than ever.
3M Medical Relaunch Focuses on Next-Generation Technologies
The 3M Medical Materials and Technology group is working on innovative applications such as wearables and lab-on-a-chip diagnostic products.
Supplier Responsibility in Medical Device Recalls
What is the responsibility of the design owner? What level of accountability does the supplier have? What follow-up actions must a supplier take? A variety of best practices need to be driven forward by both suppliers and OEMs in an organized manner to ensure patient safety.
European Device Regulations: Unannounced Audits
Critical subcontractors and crucial suppliers will be subject to unannounced audits by notified bodies under the revised European device regulations. Richard DeRisio of TÜV Süd provides more details in this presentation.
3M Medical Materials & Technologies Double-Coated Tapes & Adhesives for Medical Devices
3M Medical Materials & Technologies helps health care manufacturers design and build more reliable, innovative and feature-rich medical devices. Choose from a variety of transparent, nonwoven, or conformable double sided tapes for your medical device needs.
Reducing Risk and Providing Security in Your Global Supply Chain
Manufacturers should collaborate with a third-party logistics provider that has expertise in local in-country regulatory requirements and transportation security.
Hot Topics in Risk Management & Medical Devices
Roberta Goode, president & CEO of Goode Compliance International, weighs in on the latest challenges medical device manufacturers are facing in risk management at the MedTech Intelligence HHE, Risk Assessment, & Recalls Conference in Washington, DC.
