Author: Nikita Angane

Companies are often in doubt about outsourcing Internal Audits especially when they have an in-house quality assurance department. For small and medium-size companies, it might be a burden on their financial resources, however it is the right approach toward compliance. According...

Complaint handling can be a daunting task especially if you are a small company. 21CFR 820 requires customer complaints to be handled by a designated customer handling unit and if you are a small company this might seem a little...

As a medical device manufacturer, every company must establish a QMS in compliance with 21CFR 820 (if you sell in the US) or ISO 13485 [which is internationally recognized]. With this as a starting point, you might have the Quality...

Making a change to the design or the manufacturing process of your product that is already out in the field? You have some additional things to consider before making the change. Often times these changes are triggered via the customer...

A 510(k) is the most utilized regulatory pathway to market a medical device in the US. For a device of the same level of risks, a CE Mark is required to market a medical device in the European Economic area. In...

FDA has introduced a new program for medical devices and for device led combination products. Under this program are devices that do not qualify to be cleared via the breakthrough program but significantly improve the safety of the currently available...

With the up-classification of medical devices as per the new EU MDR, software used as a medical device has been affected the most. Under Rule 11: “Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes...

The new EU MDR and the new IVDR have some harmonized standards also known as recognized standards. The harmonized standards are those that are referenced in the Official Journal of the European Union. Devices that comply with these harmonized standards...

Clinical evidence is required to assure the safety and efficacy of a medical device for intended use pre-market. After an appropriate risk-benefit analysis, the device may still be placed on the market with the residual risk. The questions about residual...