Checkpoints for import and export of Medical Devices in the US

Medical devices are one of the world’s most traded commodities. The United States stands top in both the export and import of medical devices as per recent statistics. Considering the very natur...

Do’s and Dont’s in a Quality Audit

Quality audits play a fundamental role in the establishment of a company’s Quality Management System (QMS). An audit provides the opportunity for an organization to take corrective actions and a...

Canadian Regulations for Medical Device Manufacturers and Importers

A medical device company wanted to get into the Canadian Market to meet the requirements of many of its customers. However, they were unsure of how to begin this journey and what should be done ...

What is so special about Harmonised Standards for medical devices and IVDs?

The word “harmonised standard” means a “European standard adopted on the basis of a request made by the Commission for the application of Union harmonization legislation”, as per Regulation EU 1...

Change is inevitable – The dynamic world of Medical Device Standards and compliance

In the medical device industry, standards play a vital role in product conformity while also helping Manufacturers synchronize with requirements of medical device regulatory bodies around the wo...

ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation

In January 2021, a new member, namely ISO 10993-23, of the ISO 10993 family was released. But what created the need for the introduction of this standard in the series of ISO 10993 standards? Th...

BS EN ISO 13485:2016/A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes

The release of the 2021 Amendment of ISO 13485:2016 has created a lot of curiosity amongst medical device organizations and quality professionals. 

The question which most of us have...

Change to a Device – How could I be so naive?

Change – the necessity of time

Changes in today’s world are inevitable, and this is all to keep abreast with the fast technological advancements and to keep the customers happy and ...

CE Marking – An important requirement for the European Market

A CE Marking is a much sought-after symbol, as it allows companies to gain access to the large European market. CE Marking indicates the conformity of products to the applicable regulatory requi...

Common pitfalls during the CE marking of a Medical Device or IVD

A CE (Conformitè Europenne) Mark is mandatory for medical devices manufactured, designed, marketed, and supplied within the European Economic Area (EEA) & European Union (EU). The CE Mark is...