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BS EN ISO 13485:2016/A11:2021
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 is: “What is new in the 2021 amendment of ISO 13485 standard?” Do not worry!…

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uv-light-emiting
Health Canada’s Regulatory requirements for UV light-emitting products with claims pertaining to Covid -19

What are UV light-emitting products? UV light-emitting devices are devices that are manufactured, distributed, or used to control, destroy or deactivate viruses, bacteria, or other microorganisms, or to reduce their levels, by means of UV radiation except in swimming pools, spas, or sewage treatment plants. UV light-emitting products are usually marketed as chambers (small/large), wands, and lamps. The…

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ce-marking
What does CE Marking imply and why is it required?

Manufacturers must obtain CE marking for the products they want to sell in the European Union (EU). When a product is CE marked, it means that the product is assessed by the manufacturer and found to comply with EU safety, health, and environmental protection laws. This is a legal requirement for the products that are…

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ISO 20417:2021
ISO 20417:2021

Medical devices – What information is to be supplied by the manufacturer? As we are very much aware that the ISO 20417:2021 standard is already in town, Elexes Team has detailed in this article the need for the new labeling standard, ISO 20417:2021, which entails the information to be supplied by the manufacturers for a medical device…

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clinical-trials
The A, B, C of Clinical Trials for Medical Devices

Several medical devices undergo clinical trials on an ongoing basis. Typically, medical devices are categorized based on their invasiveness, intended purpose, risks, and classification. The categorization of the medical devices serves as a guideline for the regulatory route to be adopted for marketing authorization in the country of interest and for determining the nuances to…

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device-development
Medical device development end to end

Medical Device Development Medical device development is a comprehensive series of well-coordinated activities and events from the moment of product concept and ideation, to risk assessment and feasibility analysis, to design development verification and validation, leading to activities for the pre-launch preparation, and ultimately the product launch, market commercialization, and post-market surveillance. Medical device development…

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ISO 13485 Certification
Looking for an ISO 13485 Certification?

Introduction to Quality Management System Quality is the most important criterion to be fulfilled by medical device manufacturers to satisfy customers. Medical devices have an impact on the health of the patients, and thus various regulatory bodies across the world also mandate the implementation of the Quality Management System (QMS) for which the most widely…

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