What is the Accession Number?
To market Medical Devices that emit certain types of radiation in the U.S. (see 21 CFR 1002.1 for details), a Product [...]
29 08 2018
29 08 2018
29 08 2018
29 08 2018
Which Medical Devices are classified as electronic products that emit radiation?
If a product contains an electronic circuit and generates any type of radiation, it is classified as an electronic product emitting radiation. Medical [...]
29 08 2018
29 08 2018
What does the CDRH do?
The CDRH (Center for Devices and Radiological Health) is an organization within the US Food and Drug Administration (FDA) responsible for [...]
18 05 2018
18 05 2018
How will the IVDR 2017/746 affect the Quality System Management?
Once the transition period is over, all IVDs shall meet the requirements of the IVDR to be marketed in the European [...]
18 05 2018
18 05 2018
What does the entry into force of IVDR 2017/746 entail for manufacturers of in vitro diagnostic Medical Devices?
The complex process of developing IVDs could become difficult and take a long time for most device manufacturers. IVD manufacturers are [...]
18 05 2018
18 05 2018
When will the IVDR 2017/746 enter into force?
The IVDR came into force in May 2017, but there are five years to adjust, until May 26, 2022. During the [...]
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 [...]
