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…
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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…
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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…
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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…
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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. …
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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…
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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…
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Refuse 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…
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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) &…
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