The new playbook from the Case for Quality Collaborative Community aims to shift the mindset of device manufacturers from one of regulatory compliance to one of organization-wide quality.
Device makers that are laser-focused on regulatory compliance would be better served by shifting their mindset to one of organization-wide quality, a new playbook from the Case for Quality Collaborative Community (CfQcc) suggests.
Released on 16 February, the Leadership Engagement Playbook offers manufacturers 10 best practices for cultivating a culture of quality, as well as a framework for piloting them.
Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
German Bionic’s new exoskeleton Exia helps healthcare practitioners, nurses, and other caregivers to lift and move patients by supporting muscle movement and reducing the risk of injury.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
BD is accelerating transitions of product sourcing for China to avoid tariffs. Historically, products like Vacutainer were exported from Sumter, SC, to China, and Flush was shipped from Columbus, NE.
The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel
The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.
