PSN Labs says the expanded scope highlights its ability to support customers from concept through commercialization.

Benefits of ISO 13485 Certification for Medical Device Manufacturing ISO 13485 certification is an internationally recognized standard for medical device companies involved at any stage of a product’s ...

Cytek’s EN ISO 13485:2016 certification follows extensive analysis and audit of its QMS by TÜV Rheinland ®, an independent certification body. Cytek plans to pursue certifications for ...

Underscoring the company’s commitment to quality and excellenceSAN DIEGO, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company reimagining therapeutic ...

This course covers changes from ISO 13485:2003 to the ISO 13485:2016 standard and their impact on a company’s Quality Management System (QMS). Topics include the Annex SL framework, methods for ...

The certification was issued by DQS Med, the Notified Body appointed to assess Medibio`s submission for CE Mark. It signifies that Medibio has established a comprehensive quality system for the design ...

Receiving ISO 13485 certification indicates that a company has developed robust policies and procedures for the development and manufacture of regulated medical products.

Sensera Inc. (MicroDevices) is accredited to ISO 13485 quality standards for the production and integration of their MEMS based medical components ...

The ISO 13485:2003 certification specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that ...

This course is based on the 2016 version of the ISO 13485 Standard, providing skills necessary to perform internal process audits in the medical device industry. It features a detailed review of the ...