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When most people hear the term “medical device”, they think of surgical and hospital tools, like stethoscopes or ...
FDA has introduced a new program for medical devices and for device led combination products. Under this program ...
Do you have a low to moderate risk medical device that does not have a substantially equivalent predicate device? ...
The third version of ISO 14971 is currently being published. The new version of ISO 14971 is set for release in Q4 ...
The Special 510(k) program was established to create a more efficient review process (30 days instead of the 90 ...
ISO 14155 [Clinical investigation of medical devices for human subjects – Good clinical practice], as the name ...
Innovating the medical device regulatory process is a goal that the FDA’s Center for Devices and Radiological ...
With the up-classification of medical devices as per the new EU MDR, software used as a medical device has been ...
The new EU MDR and the new IVDR have some harmonized standards also known as recognized standards. The harmonized ...
The term “cosmeceutical” has become popular in recent years to describe a cosmetic product that claims medicinal ...
With FDA’s Food Safety and Modernization Act (FSMA), importers were given greater responsibility for ensuring that ...
Clinical evidence is required to assure the safety and efficacy of a medical device for intended use pre-market. ...
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