Safety First – Risk Management Process for medical devices, software and IVD products
As we know a medical device is a device intended for medical purposes. Such devices have numerous applications in the life of…
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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…
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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…
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Best regulatory and quality consulting firm for medical devices, IVDs, and software in India and US
Ever since the boon of the healthcare industry as one of the largest industries in the world market, multiple medical device companies…
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Accelerated pathway to the market – The know-how of Breakthrough Device Designation Request
A medical device manufacturer approached Elexes with a very unique medical device. While the product had a lot of advantages over any…
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What the Medical Device Manufacturers need to know about FDA’s UDI requirements?
All the medical device manufacturers that intend to place their devices in the US should label their devices considering the Unique Device Identifier (UDI)…
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Why and how do Medical Device Manufacturers conduct an Internal Audit?
The purpose of conducting an Internal Audit is to evaluate the efficiency of an organization in terms of quality processes, risk management,…
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Time to revisit your Medical Device’s classification in Australia (TGA): Reclassification Update in Brief
Alert Call for Medical Device Manufacturers who are looking to place the Spinal Implantable or any other type of Medical Devices in the Australian…
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How can a Medical Device Single Audit Program (MDSAP) certification help a Medical Device Manufacturer?
Are you one of the many Medical Device Manufacturers who is struggling to figure out the potential benefits of the Medical Device Single…
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