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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 medical devices as per recent statistics. Considering the very nature of medical devices, testing their safety and efficacy becomes crucial as they directly impact the health and lives of mankind. Manufacturers must adhere…

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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 an organization to take corrective actions and address the identified non-conformances to get its processes in line with its intended goals. Regulatory authorities across the globe have mandated manufacturers to undertake initial and…

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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 were unsure of how to begin this journey and what should be done to achieve authorization to sell legally within Canada. Primary objectives: The primary objectives of the medical device company were to:…

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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 of Union harmonization legislation”, as per Regulation EU 1025/201. The prefix “EN” such as EN ISO 14971:2012 or EN ISO 13485:2016, are used to identify such standards. These harmonised standards are used to…

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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 technological advancements and to keep the customers happy and content. But when you are in the medical device industry, something you cannot be naive about is that every change comes with a price. …

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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 indicates the conformity of products to the applicable regulatory requirements, and the performance and safety standards. It signifies that the product is suited for its intended use and won’t put people or property…

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