Medical device companies, listen up. There is zero excuse for not complying with medical device quality system regulations. FDA has published and makes available ALL regulations required for medical ...
What is ISO 13458? This is the easy part; ISO 13485 specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical device ...
This seminar offers medical device manufacturers the opportunity to enhance efficiency and compliance by applying Lean Documentation and Lean Configuration principles. Led by expert Jose Mora, it ...
DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Statistical Process Control" conference to their offering. This two-day workshop provides the information you need to ...
CHADDS FORD, Pa., July 29, 2025 /CNW/ -- ClariMed, Inc., a global leader in human-centered medical device development and regulatory services, today announced it has achieved ISO 13485:2016 ...
SEATTLE--(BUSINESS WIRE)--Kubota Vision Inc. (“Kubota Vision” or the “Company”), a clinical-stage specialty ophthalmology company and a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., ...
Design Controls are defined in FDA 21 CFR 820.30 and in section 7.3 of ISO 13485. Design Controls are a systematic framework for capturing key aspects of medical device product development to prove ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback