Ensure your AI systems in MedTech meet compliance standards. Join our webinar on AI governance strategy and regulatory best ...

CAPA PROCESS STEPS The CAPA process comprises seven steps as highlighted below. Step-by-step risk-based CAPA process Identification Evaluation Investigation & Analysis Action Plan Review and ...

Records and Documents in QMS linking is a feature in QMS to help identify the pairs of relevant information representing the same entity.

The validation process for USFDA medical device applications can be pretty complex and time-consuming. The first step in the validation.

Packaging and sterilization validations are a critical step in the development and manufacturing of medical devices, as they ensure patient safety, regulatory compliance, product quality, and the ...

Change management is when an organization creates a step-by-step protocol to manage and implement modifications to products and processes. A change management plan is a protocol that implements and ...

ISO 9001 enables an organization to adjust the documentation as applicable as long as the overall objectives are met.

Polarion REST APIs provide access to most of the ALM platform functionalities. In this blog, we have discussed the features of Polarion REST API and reasons to use REST API for streamlining workflows.

Document control is the process of maintaining documents enforcing controlled procedures and practices for creation.

FDA (Food and Drug Administration) issued a draft guidance to offer recommendations on Computer Software Assurance (CSA) for automated data processing systems that are used as a part of medical device ...

A risk management plan (RMP) must be developed at the start of the risk management process for a new project or device development.