What is MDSAP?
The Medical Device Single Audit Program (MDSAP) allows Auditing Organizations (AO) recognized and accredited by the Regulatory Authorities of the five [...]
23 08 2019
23 08 2019
19 07 2017
19 07 2017
cGMp FDA: when can I exclude the design from my quality system according to the US cGMP?
The design is excluded for some class I devices or when it is carried out by other subject responsible for it. [...]
19 07 2017
19 07 2017
How many reviews should I expect during the device design ?
Quality systems standards do not specify how many reviews I should expect during the device design prior to its conclusion, that [...]
19 07 2017
19 07 2017
Marketing in Canada: what are the disclosure obligations required by Directive SOR 98-282?
Annually and within November 1st, the manufacturer must submit a document to the Ministry: • confirming that all information and documents [...]
19 07 2017
19 07 2017
GMP FDA: which production processes should I validate?
GMP means “Good Manufacturing Practices”. The GMP requirements, defined by the US Food & Drug Administration, relate to all company’s operational [...]
