Viewpoints
Writing Technical, Practical, and Theoretically interesting blogs
SARACA's success in the Aerospace and Defense (A&D) Industry.
Growing at 200% CAGR | Strengthening the Indian Defense | Learn from the emerging market leader How SARACA is helping the A&D Industry: SARACA has built strong capabilities in the A&D Industry and proudly delivers engineering services to 4 Fortune 500 companies. The wavelength of SARACA’s capability deck can be measured by its agreement with a 100-year-old conglomerate in India...
Jun 27, 2022
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Key highlights of the revised Swiss Medical Device Ordinance
MedDO stands for Medical Device Ordinance and is a set of rules for medical devices introduced into the Swiss market. Earlier, Switzerland has taken over the European Union (EU) system of compliance assessment and certification, based on Mutual recognition agreements (MRA).Because Switzerland is a European country and not a member of European Union, a mutual recognition agreement (MRA) is...
Feb 26, 2022
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The Helsinki procedure for borderline and combination medical devices
Having a clear understanding of the classification of devices is crucial for medical device manufacturers to bring new products to market. There are certain products, such as an eye drop, which is said to be a combination of a medical device and medicinal product. Recognizing the device classification for such borderline and combination products is often challenging. The Helsinki Procedure...
Feb 10, 2022
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Unique ID for Clinical Investigations under MDR
Conducting a clinical trial is probably the most tedious process that a medical device manufacturer must go through. The clinical investigations are conducted to meet regulatory requirements related to the generation of clinical data in support of safety and/or clinical performance for CE marking or maintaining the CE mark of the subject device. MDD dedicated just one article related to...
Feb 02, 2022
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