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…
Read articleWhat 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…
Read articleChange 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…
Read articleISO 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…
Read articleBS 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. …
Read articleChange 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…
Read articleCE 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…
Read articleRefuse to Accept – An important milestone for your device during the FDA review process
Why RTA? The FDA conducts an acceptance review of a 510(k) submission (Traditional 510(k), Abbreviated 510(k), or Special 510(k)) against acceptance criteria…
Read articleCommon 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) &…
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