The implementation and management of the compliance process with standards, laws and regulations is necessary to market Medical Devices and IVDs [...]
The definition of which standards, laws and regulations to include in the list of external source documents depends on the regulatory [...]
Documents of external origin are checked by Notified Bodies during CE certification process, by Certification Bodies during ISO 13485:2016 certification process [...]
As of May 26, 2021, Switzerland has fully-fledged become a Third Country (Swiss Exit) and Swiss Manufacturers are treated as any [...]
Starting from May 26, 2021, in accordance with the full application of MDR (EU) 2017/745 Regulation on Medical Devices and in [...]
The designation of the Swiss Authorised Representative (CH REP) is required to market all Medical Devices, including legacy devices, i.e. devices [...]
Since Switzerland is considered a Third Country by the EU, its registration database is denied. Swiss REP and Importer in Switzerland [...]
The European Parliament, by publishing the EU 2022/112 Regulatory, modified the transitional periods, initially foreseen by IVDR art. 110, as following: [...]
The goal of the “Sell Off” provision (IVDR art. 110 para 4) is to reduce the amount of time in which [...]
In most cases, Class A devices can be self-certified, unless they are sold sterile, while for Class B, C and D [...]
Thema srl
Via Saragat, 5
40026 Imola (BO) – Italy
Tel. +39 0542 643496
Fax. +39 0542 641833
info@complifegroup.com
Thema Corp
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Tel. +1 215-845-9459
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