This article will provide an overview of the internal audit process in the medical device industry, covering essential audit terminology such as audit program, conformity and audit findings.
Effective planning is a cornerstone of any successful internal audit, and one essential tool that auditors often rely on is an internal audit checklist.
This article breaks down what an audit checklist is, if it is required, best practices, and tips for avoiding common pitfalls.
This illustrated guide provides a useful overview of IEC 62304, clarifies terminology used in the standard, and addresses common misconceptions in medical device software development.
Implementing a medical device quality management system, or QMS, is a regulatory requirement. In the medical device industry, there is a strong focus on the regulatory requirements but a QMS should also make the organisation efficient and result in products that have high quality.
The requirement of having a policy for establishing criteria for risk acceptability was added in the ISO 14971:2019 version of the standard was because the concept was often misunderstood in the previous 2007 version of the standard.
Among other things, this illustrated guide provides a useful overview of quality management for medical devices and ISO 13485, clarifies terminology used in the ISO 13485 standard that is defined elsewhere, and addresses common misconceptions.
This article covers the responsibilities of the sponsor – one of the most important stakeholders in a clinical investigation. Some of the main responsibilities include The main sponsor responsibilities are: clinical quality management, communication with regulatory authorities, clinical investigation planning and conduct, and outsourcing duties and functions.
To achieve the purpose of the manufacturer’s PMS system, the manufacturer must have a PMS plan. This is also stated in Article 84 of the MDR. But article 84 basically only references Annex III, which is the annex that describes the requirements on the technical documentation of the PMS.
Comparing the least expensive version with the most expensive ones will result in a price difference of 1400%. The price at the Estonian Centre for Standardisation is significantly lower than the others. Find out where to buy and download the standard.
Performing risk evaluation is perhaps the easiest part of risk management. Yet, it is important to know how to do it properly to perform risk management successfully.
Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course.
These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.
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