The fact that the device is always the same may be a plus point for obtaining CE certification. Still, nevertheless, data [...]
The consultancy route, particularly if one relies on a structured company, is the best choice to speed up the process of [...]
The MDR compliance process does not allow for haste and requires the right timing to resolve and fill all deficiencies. Compared [...]
Having an ISO 13485:2016-certified quality management system is an excellent starting point; being a harmonised standard, it confers a presumption of [...]
The requirements for obtaining the CE certificate are very stringent because devices placed on the EU market must be safe and [...]
On February 19, 2024, the Australian regulatory authority, Therapeutic Good Administration (TGA), updated the requirements regarding the labelling of medical [...]
April 1, 2024, represents a very significant date for the Medical Devices market in Canada. First, from this date, modified [...]
On March 6, 2024, the European Commission amended Implementing Decision (EU) 2021/1182 on harmonised standards for single-use medical gloves, biological [...]
What is Quality System 21 CFR Part 820? FDA 21 CFR Part 820 is a regulatory framework governing the quality [...]
This article proposes that Medical Device Manufacturers embark on a journey through Europe, America and Asia to discover the main deadlines [...]
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