Newsletter | June 6, 2026

06.06.26 -- Med Device Online Best Of May

FEATURED EDITORIAL

Minding The Gap: Submission Strategies For Combined Use Combination Products

For combination product regulatory submissions, there is no one-size-fits-all approach. Regulatory pathways and application types vary across global health authorities.

New Sustainability Mandates In Brazil And Chile Are Quietly Disqualifying Medical Devices

The integration of environmental criteria into Latin American medical device procurement is not a temporary policy experiment; it represents a structural market transformation. 

Selecting The Right eQMS To Maximize Quality Maturity

Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.

TOP INDUSTRY INSIGHTS

What Factors Impact Quality For Medical Device Manufacturers?

This article asks Corporate Vice President of Quality at B. Braun Medical Inc. about how quality is impacted in medical device companies by FDA regulations, collected data, and more.

Key Changes To Biocompatibility And Updates To New FDA Draft Guidance

Review key changes in the upcoming version of ISO 10993-1, regulatory expectations for specific in vitro and in vivo assays, and the FDA's expectations regarding chemical characterization.

Color Consistency In UHMWPE Medical Textiles

Color consistency improves surgical visibility, differentiation, and workflow efficiency, requiring medical textiles that deliver strength, compliance, and reliable quality in every color.

TOP RESOURCES

ISO 80369 Compliant Connectors

Tooling Solutions Sell Sheet

An Introduction To Validation Of Aseptic Fill/Finish And Related Processes

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