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June Newsletter 2023

EUROPEAN UNION Implementation of Regulation (EU) 2023/1194 on transitional provisions for products...

May Newsletter 2023

EUROPEAN UNION (EU) Updated MHRA guidance on significant changes under MDR | 12 May 2023 The...

April Newsletter 2023

Germany Database for In vitro diagnostics Medical Devices notification | 25 April 2023 In Vitro...

March Newsletter 2023

EUROPEAN UNION (EU) Guidance on MDR transitional period extension | 28 March 2023 The amendment of...

February Newsletter

EUROPEAN UNION (EU) MDCG guidance on vigilance terms and concepts of EU MDR | 14 February 2023 The...

November Newsletter

EUROPEAN UNION (EU) EU guidance on reference laboratories for IVD medical devices | 30 November...

October Newsletter 2022

EUROPEAN UNION (EU) Guidance on EU Authorized Representatives | 31 October 2022 Medical Device...

September Newsletter 2022

EUROPEAN UNION (EU) Notified Bodies Position paper on application of hybrid audits for QMS...

August Newsletter 2022

EUROPEAN UNION (EU) MDCG guidance on Notified body capacity and availability of medical devices...

July Newsletter 2022

EUROPEAN UNION (EU) Harmonised administrative practices and alternative technical solutions| 13...




Software As a Medical Device and Its Clinical Evaluation

Software As a Medical Device and Its Clinical Evaluation

Software as a medical device (SaMD) refers to a class of medical software that performs one or more medical tasks independently of a physical medical device. It can interface with other medical equipment or software or be utilised with non-medical computer platforms like smartphones. It may be used for a number of objectives, including illness detection, diagnosis, treatment, or prevention. The quality of life for patients and providers can be enhanced through its interactions with data. Regulation is necessary for SaMD since it is a novel and creative technology that must be safe.

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Authorised Representatives 

Nomenclature of Medical Devices

Nomenclature of Medical Devices

‘Medical devices’ is an umbrella term that includes products for the prevention, diagnosis, and treatment of numerous diseases. Medical devices require an internationally accepted naming to identify the various types and categories. Nomenclature of medical devices helps understand the medical device’s risk class, definition, and use.

Swiss Manufacturer Obligations

Swiss Manufacturer Obligations

1. Manufacturers outside Switzerland will need to appoint Swiss AR. 2. The Manufacturer will use commercially reasonable efforts to update its technical documentation for the devices, to comply with the requirements of the ordinance, and to...