06. September 2018
DEKRA and SGS became fully recognized MDSAP audition Organizations.

27. August 2018
A notice published by ISO indicates that the FDA may be considering to replace the Current Quality System requirements (as published under 21CFR820) by the ISO 13485 already in 2019. This would create a further step to the global harmonization....

21. August 2018
Health Canada is introducing a new structure for the submission of device license information of class III and IV products following the INDRF Guidance on nIVD(MA)ToC.

01. August 2018
The annual update or the FDA user fees is now available on the FDA Website.

30. Juli 2018
A brief presentation prepared by the EU Commission answers the typical questions concerning the preparation of the Notified Bodies under the new MDR.

24. Juli 2018
In preparing the implementation of the new MDR requirements manufacturers should consider this Checklist prepared by the MHRA.

20. Juli 2018
The Factsheet for Manufacturers of Medical Devices was published by the EU Commission.

03. Juli 2018
The revised "Guidelines for Auditing Management Systems" is intended "to lift the audit to a higher level" and is not only addressing the auditors....

01. Juli 2018
As of 2018-07-01 no product may be marketed in Malaysia not being registered before.

07. Juni 2018
With the modification FDA introduced some new standards that require some attention.

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