DDx for effective diagnosis and the regulatory repercussions
“True prevention is not waiting for bad things to happen, it’s preventing things from happening in the first place.” Diagnosis in today’s…
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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…
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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…
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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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