22/11/2024 The European Commission has recently published a document entitled 'Q&A Obligation to inform in case of interruption or discontinuation of [...]
22/11/2024 In the wake of the increasing technological development in the medical device sector, the Saudi Food and Drug Authority (SFDA) [...]
22/11/2024 In October 2024, the Medical Device Coordination Group (MDCG) published the updated version of MDCG Guideline 2022-5 Rev. 1, entitled [...]
The European Union's MDR (EU) 2017/745 requires medical device manufacturers to adopt a systematic Post-Market Surveillance (PMS) process to ensure the [...]
18/10/2024 On October 8, 2024, the Medical Device Coordination Group (MDCG) of the European Commission published the MDCG 2024-11 - Guidance [...]
18/10/2024 On September 15, 2024, the FDA updated three draft guidelines related to ASCA (Basic Safety and Essential Performance), a voluntary [...]
18/10/2024 On October 1, 2024, the FDA's Centre for Devices and Radiological Health (CDRH) in the US announced that devices with [...]
Change management in Medical Devices is essential to ensure European and international compliance. After the product is first placed on the [...]
In Australia, the Essential Principles represent a set of mandatory requirements designed to ensure that Medical Devices placed on the market [...]
The US Food and Drug Administration (FDA) recently announced in a guidance issued on August 23, 2024, entitled 'Electronic Submission Template [...]
Thema srl
Via Saragat, 5
40026 Imola (BO) – Italy
Tel. +39 0542 643496
Fax. +39 0542 641833
info@complifegroup.com
Thema Corp
B+Labs c/o Cira Center
2929 Arch Street, Floor 4
Philadelphia, PA 19104 – U.S.A.
Tel. +1 215-845-9459
© Copyright Thema srl – 2024 | | All Rights Reserved – C.F./P.IVA IT02770361208 N. REA BO n.466056 | Cap. Soc.€ 50.000 i.v.
