Penta Nanotechnology (Suzhou) Co., Ltd. has officially announced its attainment of the ISO 13485 certification, marking a significant milestone as a premier Certified Parylene Coating Equipment ...

Medical device companies MUST have established risk management processes that comply with ISO 14971. And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on. ISO ...

THY Precision (Hong Yang Precision ) is an ISO 13485–certified medical plastic injection molding manufacturer with cleanroom injection molding and assembly. THY Precision offers medical device ...

ZAVENTEM, Belgium, May 20, 2025 (GLOBE NEWSWIRE) -- SYNDEO Medical, a Belgian-based developer of interventional procedure solutions, is pleased to announce that it has received ISO 13485 certification ...

The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...

The medical technology industry has gone through some changes in the last 14 years, as has its regulatory environment, and it was time that ISO 13485 reflected that evolution. The global standard for ...

Dublin, Jan. 27, 2026 (GLOBE NEWSWIRE) -- The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course (May 21, 2026)" training has been added to ...